Trial Outcomes & Findings for AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (NCT NCT04885998)
NCT ID: NCT04885998
Last Updated: 2025-09-29
Results Overview
A DLT was any of the following during the DLT window, assessed by Common Terminology Criteria for Adverse Events v4.0: * Grade 3 adverse event (AE) except for fatigue lasting \< 7 days, Grade 3 nonfebrile neutropenia that improved to ≤ Grade 1 within 3 weeks, endocrinopathies if managed with replacement therapy, Grade 3 nausea/vomiting or diarrhea for \< 72 hours, Grade 3 amylase or lipase values not associated with pancreatitis, Grade 3 hematologic laboratory abnormalities not clinically relevant, or Grade 3 electrolyte abnormality up to 72 hours. * Grade 4 AE except for Grade 4 nonfebrile neutropenia lasting ≤ 7 days, Grade 4 electrolyte abnormality lasting up to 72 hours, Grade 4 amylase or lipase values not associated with pancreatitis, or Grade 4 hematologic laboratory abnormalities no clinically relevant. * Grade 5 AE * Recurrent Grade ≥ 2 pneumonitis * Any other toxicity requiring permanent discontinuation of AMG 404.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
First dose of tarlatamab up to 28 days
Results posted on
2025-09-29
Participant Flow
Participants were enrolled at 10 research centers in Belgium, Japan, Singapore, Taiwan, and the United States between 27 September 2021 and 11 September 2024. The final analysis data is presented.
Adults with confirmed diagnosis of small cell lung cancer who progressed or recurred following ≥1 platinum-based treatment regimen were enrolled into sequential dose-exploration (Part 1) and dose-expansion (Part 2) cohorts to receive tarlatamab + AMG 404. Tarlatamab doses ranged from Dose A to Dose D (lowest to highest). The primary outcome measures have been updated, as 1 participant was found post-database lock to have been misclassified in Part 1 (Cohort 3) instead of Part 2.
Participant milestones
| Measure |
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
Participants received tarlatamab administered intravenously (IV) with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose C on cycle 1 day 8 and cycle 1 day 15, and Dose C Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose D on cycle 1 day 8 and cycle 1 day 15, and Dose D Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
3
|
8
|
|
Overall Study
Safety Analysis Set
|
7
|
5
|
3
|
8
|
|
Overall Study
Entered Extended Safety Period (EP)
|
6
|
1
|
1
|
4
|
|
Overall Study
COMPLETED
|
3
|
0
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
2
|
5
|
Reasons for withdrawal
| Measure |
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
Participants received tarlatamab administered intravenously (IV) with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose C on cycle 1 day 8 and cycle 1 day 15, and Dose C Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose D on cycle 1 day 8 and cycle 1 day 15, and Dose D Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
|
Overall Study
Death
|
2
|
1
|
2
|
2
|
|
Overall Study
Decision by sponsor
|
1
|
1
|
0
|
0
|
Baseline Characteristics
AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
Baseline characteristics by cohort
| Measure |
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
n=7 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
n=5 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose C on cycle 1 day 8 and cycle 1 day 15, and Dose C Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
n=3 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose D on cycle 1 day 8 and cycle 1 day 15, and Dose D Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404
n=8 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
59.3 years
STANDARD_DEVIATION 18.4 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
60.2 years
STANDARD_DEVIATION 11.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 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
|
|
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
|
PRIMARY outcome
Timeframe: First dose of tarlatamab up to 28 daysPopulation: The DLT analysis set included all enrolled participants who received at least 1 dose of tarlatamab or AMG 404 during the dose exploration part of the study with an evaluable DLT endpoint. DLT evaluable endpoints included: 1. participant experienced a DLT; or 2. participant did not experience a DLT and received tarlatamab or AMG 404 treatment as planned in cycle 1 and had been followed for safety events a minimum of 28 days from the date of first dose administration of tarlatamab.
A DLT was any of the following during the DLT window, assessed by Common Terminology Criteria for Adverse Events v4.0: * Grade 3 adverse event (AE) except for fatigue lasting \< 7 days, Grade 3 nonfebrile neutropenia that improved to ≤ Grade 1 within 3 weeks, endocrinopathies if managed with replacement therapy, Grade 3 nausea/vomiting or diarrhea for \< 72 hours, Grade 3 amylase or lipase values not associated with pancreatitis, Grade 3 hematologic laboratory abnormalities not clinically relevant, or Grade 3 electrolyte abnormality up to 72 hours. * Grade 4 AE except for Grade 4 nonfebrile neutropenia lasting ≤ 7 days, Grade 4 electrolyte abnormality lasting up to 72 hours, Grade 4 amylase or lipase values not associated with pancreatitis, or Grade 4 hematologic laboratory abnormalities no clinically relevant. * Grade 5 AE * Recurrent Grade ≥ 2 pneumonitis * Any other toxicity requiring permanent discontinuation of AMG 404.
Outcome measures
| Measure |
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
n=6 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
n=5 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose C on cycle 1 day 8 and cycle 1 day 15, and Dose C Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
n=3 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose D on cycle 1 day 8 and cycle 1 day 15, and Dose D Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
|---|---|---|---|---|
|
Part 1: Number of Participants Who Experienced Dose-limiting Toxicity (DLT)
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Any TEAEs: From first IP dose up to last dose + 65 days or EOS, median duration was 4.2 months; TEAEs for EP: From last dose + 65 days up to snapshot date (15 November 2024), death, or last dose + 145 days or EOS, median duration was 2.6 monthsPopulation: The safety analysis set included all participants who received at least 1 dose of tarlatamab or AMG 404. For any TEAEs, categories included those that occurred before or during the EP. For the EP, data are presented for participants who entered the EP. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
An AE was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was an AE that started on or after the first dose of investigational product (IP; tarlatamab) up to 65 days after the last dose of tarlatamab or AMG 404 or the end of study (EOS), whichever was earlier. A TEAE for the EP was an AE that occurred after the 65th day after the last dose of tarlatamab or AMG 404 up to 145 days after the last dose of tarlatamab or AMG 404 or end of study, whichever was later. A treatment-related AE was any TEAE where there was a reasonable possibility that the TEAE could have been caused by tarlatamab or AMG 404. Any clinically significant changes in vital signs, physical examinations, electrocardiograms, and clinical laboratory tests were included as TEAEs.
Outcome measures
| Measure |
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
n=7 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
n=5 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose C on cycle 1 day 8 and cycle 1 day 15, and Dose C Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
n=3 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose D on cycle 1 day 8 and cycle 1 day 15, and Dose D Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404
n=8 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Any TEAE
|
7 Participants
|
5 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Any tarlatamab-related TEAE
|
6 Participants
|
5 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Any AMG 404-related TEAE
|
6 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
EP: Any TEAE
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
EP: Any tarlatamab-related TEAE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
EP: Any AMG 404-related TEAE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of IP up to a minimum of last dose date + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) monthsPopulation: The safety analysis set included all participants who received at least 1 dose of IP (tarlatamab or AMG 404).
The objective response rate was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the modified RECIST v1.1. CR: complete disappearance of all lesions and pathologic lymph nodes reduced in short axis to \< 10 mm. PR: decrease in tumor burden of ≥ 30% relative to baseline, or complete disappearance of all index lesions with the presence of non-index lesions. Confirmation scans were required within 4 weeks of the first documented response of CR or PR. Exact 95% confidence intervals (CIs) were calculated using the Clopper-Pearson method.
Outcome measures
| Measure |
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
n=7 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
n=5 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose C on cycle 1 day 8 and cycle 1 day 15, and Dose C Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
n=3 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose D on cycle 1 day 8 and cycle 1 day 15, and Dose D Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404
n=8 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
|---|---|---|---|---|
|
Objective Response Rate Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
SECONDARY outcome
Timeframe: From first dose of IP up to a minimum of last dose date + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) monthsPopulation: The safety analysis set included all participants who received at least 1 dose of IP (tarlatamab or AMG 404). Data is presented for participants who achieved a best overall response of PR or CR.
The duration of response was defined as the time from first evidence of CR or PR to progressive disease (PD) or death due to any cause, whichever occurred first, estimated via Kaplan-Meier methods. CR: complete disappearance of all lesions and pathologic lymph nodes reduced in short axis to \< 10 mm. PR: decrease in tumor burden of ≥ 30% relative to baseline, or complete disappearance of all index lesions with the presence of non-index lesions. Confirmation scans were required within 4 weeks of the first documented response of CR or PR. PD: radiologic detection of ≥ 20% increase in tumor burden relative to nadir and ≥ 5 mm absolute increase, or unequivocal progression of non-index lesions, or presence of new lesions. 95% CIs were calculated using the Brookmeyer and Crowley method.
Outcome measures
| Measure |
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
n=4 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
n=1 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose C on cycle 1 day 8 and cycle 1 day 15, and Dose C Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
n=2 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose D on cycle 1 day 8 and cycle 1 day 15, and Dose D Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404
n=3 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
|---|---|---|---|---|
|
Duration of Response Per Modified RECIST v1.1
|
NA months
Interval 3.9 to
Median and upper confidence interval (CI) were not calculable as median was not reached due to insufficient event data occurring.
|
6.0 months
Upper and lower CIs were not calculable due to only 1 participant achieving OR.
|
8.1 months
Interval 4.7 to
Upper CI was not calculable due to insufficient event data occurring above the median.
|
11.2 months
Interval 5.6 to
Upper CI was not calculable due to insufficient event data occurring above the median.
|
SECONDARY outcome
Timeframe: From first dose of IP up to a minimum of last dose date + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) monthsPopulation: The safety analysis set included all participants who received at least 1 dose of IP (tarlatamab or AMG 404).
The disease control rate was defined as the percentage of participants with a best overall response of a confirmed response (CR/PR) or stable disease (SD) while on the study as defined by modified RECIST v1.1. CR: complete disappearance of all lesions and pathologic lymph nodes reduced in short axis to \< 10 mm. PR: decrease in tumor burden of ≥ 30% relative to baseline, or complete disappearance of all index lesions with the presence of non-index lesions. Confirmation scans were required within 4 weeks of the first documented response of CR or PR SD: Index lesions not meeting the criteria for CR, PR, or PD or the persistence of one or more non-index lesions. Exact 95% CIs were calculated using the Clopper-Pearson method.
Outcome measures
| Measure |
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
n=7 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
n=5 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose C on cycle 1 day 8 and cycle 1 day 15, and Dose C Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
n=3 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose D on cycle 1 day 8 and cycle 1 day 15, and Dose D Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404
n=8 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
|---|---|---|---|---|
|
Disease Control Rate Per Modified RECIST v1.1
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
60.0 percentage of participants
Interval 14.7 to 94.7
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
SECONDARY outcome
Timeframe: From first dose of IP up to a minimum of EOS or death; median (min, max) time was 9.4 (0.4, 25.5) monthsPopulation: The safety analysis set included all participants who received at least 1 dose of IP (tarlatamab or AMG 404).
Progression-free survival was defined as the interval from the earlier date of the first dose of IP to the earlier of PD per modified RECIST v1.1 or death due to any cause, estimated via Kaplan-Meier methods. PD: radiologic detection of ≥ 20% increase in tumor burden to nadir and ≥ 5 mm absolute increase, or unequivocal progression of non-index lesions, or the presence of new lesions. Confirmation scans were required within 4 weeks of the first documented response of CR or PR, and 4-6 weeks for PD. 95% CIs were calculated using the Brookmeyer and Crowley method.
Outcome measures
| Measure |
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
n=7 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
n=5 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose C on cycle 1 day 8 and cycle 1 day 15, and Dose C Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
n=3 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose D on cycle 1 day 8 and cycle 1 day 15, and Dose D Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404
n=8 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
|---|---|---|---|---|
|
Progression-free Survival Per Modified RECIST v1.1
|
6.5 months
Interval 0.4 to
Upper CI was not calculable due to insufficient event data occurring above the median.
|
3.8 months
Interval 1.8 to
Upper CI was not calculable due to insufficient event data occurring above the median.
|
6.5 months
Interval 3.0 to
Upper CI was not calculable due to insufficient event data occurring above the median.
|
7.4 months
Interval 1.6 to
Upper CI was not calculable due to insufficient event data occurring above the median.
|
SECONDARY outcome
Timeframe: From first dose of IP up to a minimum of EOS or death; median (min, max) time was 9.4 (0.4, 25.5) monthsPopulation: The safety analysis set included all participants who received at least 1 dose of IP (tarlatamab or AMG 404).
Overall survival was defined as the interval from the earlier date of the first dose of IP to the event of death due to any cause, estimated via Kaplan-Meier methods. Participants who were still alive were censored at the date last known to be alive. If the date last known to be alive was after the data cutoff date, the participant was censored at the analysis trigger date. 95% CIs were calculated using the Brookmeyer and Crowley method.
Outcome measures
| Measure |
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
n=7 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
n=5 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose C on cycle 1 day 8 and cycle 1 day 15, and Dose C Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
n=3 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose D on cycle 1 day 8 and cycle 1 day 15, and Dose D Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404
n=8 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
|---|---|---|---|---|
|
Overall Survival
|
NA months
Interval 0.4 to
Median and upper confidence interval (CI) were not calculable as median was not reached due to insufficient event data occurring.
|
NA months
Interval 2.7 to
Median and upper confidence interval (CI) were not calculable as median was not reached due to insufficient event data occurring.
|
6.5 months
Interval 3.0 to
Upper CI was not calculable due to insufficient event data occurring above the median.
|
NA months
Interval 4.8 to
Median and upper confidence interval (CI) were not calculable as median was not reached due to insufficient event data occurring.
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 (pre-dose up to 7 days post-dose); Cycle 2 Day 15 (pre-dose up to 14 days post-dose)Population: The pharmacokinetic (PK) analysis set included all participant who had received at least 1 dose of tarlatamab and had at least 1 PK sample collected. Participants with data available at each timepoint are presented.
Cmax was obtained using noncompartmental analysis, which was performed for tarlatamab PK parameter estimation. PK analysis is presented per dose received as pre-specified.
Outcome measures
| Measure |
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
n=12 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
n=4 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose C on cycle 1 day 8 and cycle 1 day 15, and Dose C Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
n=1 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose D on cycle 1 day 8 and cycle 1 day 15, and Dose D Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Tarlatamab in Combination With AMG 404
Cycle 2 Day 1
|
2.98 micrograms per milliliter
Geometric Coefficient of Variation 37
|
8.12 micrograms per milliliter
Geometric Coefficient of Variation 28
|
28.1 micrograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculable due to only 1 participant having available data
|
—
|
|
Maximum Observed Concentration (Cmax) of Tarlatamab in Combination With AMG 404
Cycle 2 Day 15
|
3.29 micrograms per milliliter
Geometric Coefficient of Variation 40
|
5.54 micrograms per milliliter
Geometric Coefficient of Variation 64
|
21.2 micrograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculable due to only 1 participant having available data
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 15 (pre-dose)Population: PK analysis set included all participant who had received at least 1 dose of tarlatamab and had at least 1 PK sample collected. Participants with data available are presented.
Ctrough was obtained at the end of a dosing interval or just before the administration of the next planned dose using noncompartmental analysis, which was performed for tarlatamab PK parameter estimation. PK analysis is presented per dose received as pre-specified.
Outcome measures
| Measure |
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
n=6 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
n=4 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose C on cycle 1 day 8 and cycle 1 day 15, and Dose C Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
n=1 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose D on cycle 1 day 8 and cycle 1 day 15, and Dose D Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Tarlatamab in Combination With AMG 404
|
0.380 micrograms per milliliter
Geometric Coefficient of Variation 27
|
0.893 micrograms per milliliter
Geometric Coefficient of Variation 37
|
6.59 micrograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculable due to only 1 participant having available data
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 (pre-dose up to 7 days post-dose); Cycle 2 Day 15 (pre-dose up to 14 days post-dose)Population: PK analysis set included all participant who had received at least 1 dose of tarlatamab and had at least 1 PK sample collected. Participants with data available at each timepoint are presented.
AUC0-336 was defined as the actual body exposure to the drug over time following administration of a dose, calculated from time zero to 336 hours post-dose using noncompartmental analysis, which was performed for tarlatamab PK parameter estimation. PK analysis is presented per dose received as pre-specified.
Outcome measures
| Measure |
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
n=11 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
n=4 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose C on cycle 1 day 8 and cycle 1 day 15, and Dose C Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
n=1 Participants
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose D on cycle 1 day 8 and cycle 1 day 15, and Dose D Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to 336 Hours (AUC0-336) of Tarlatamab in Combination With AMG 404
Cycle 2 Day 1
|
378 hours*micrograms per milliliter
Geometric Coefficient of Variation 39
|
1060 hours*micrograms per milliliter
Geometric Coefficient of Variation 31
|
4180 hours*micrograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculable due to only 1 participant having available data
|
—
|
|
Area Under the Concentration-time Curve From Time 0 to 336 Hours (AUC0-336) of Tarlatamab in Combination With AMG 404
Cycle 2 Day 15
|
336 hours*micrograms per milliliter
Geometric Coefficient of Variation 37
|
621 hours*micrograms per milliliter
Geometric Coefficient of Variation 72
|
3950 hours*micrograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculable due to only 1 participant having available data
|
—
|
Adverse Events
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
Serious events: 5 serious events
Other events: 7 other events
Deaths: 1 deaths
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 (EP)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 (EP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404 (EP)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404 (EP)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 2 deaths
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/B + AMG 404
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
n=7 participants at risk
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 (EP)
n=6 participants at risk
Participants in Part 1 Cohort 1 who entered the EP from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
n=5 participants at risk
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose C on cycle 1 day 8 and cycle 1 day 15, and Dose C Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 (EP)
n=1 participants at risk
Participants in Part 1 Cohort 2 who entered the EP from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
n=3 participants at risk
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose D on cycle 1 day 8 and cycle 1 day 15, and Dose D Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404 (EP)
n=1 participants at risk
Participants in Part 1 Cohort 3 who entered the EP from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404 (EP)
n=4 participants at risk
Participants in the Part 2 Dose Expansion Cohort who entered the EP from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/B + AMG 404
n=8 participants at risk
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days. Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
General disorders
Sudden death
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Immune system disorders
Cytokine release syndrome
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
25.0%
2/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
100.0%
1/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Encephalopathy
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Neurological decompensation
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Neurotoxicity
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Psychiatric disorders
Confusional state
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
16.7%
1/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
Other adverse events
| Measure |
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404
n=7 participants at risk
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 (EP)
n=6 participants at risk
Participants in Part 1 Cohort 1 who entered the EP from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404
n=5 participants at risk
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose C on cycle 1 day 8 and cycle 1 day 15, and Dose C Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 (EP)
n=1 participants at risk
Participants in Part 1 Cohort 2 who entered the EP from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404
n=3 participants at risk
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose D on cycle 1 day 8 and cycle 1 day 15, and Dose D Q2W thereafter. Each cycle was 28 days.
Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404 (EP)
n=1 participants at risk
Participants in Part 1 Cohort 3 who entered the EP from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404 (EP)
n=4 participants at risk
Participants in the Part 2 Dose Expansion Cohort who entered the EP from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404.
|
Part 2 Dose Expansion Cohort: Tarlatamab Dose A/B + AMG 404
n=8 participants at risk
Participants received tarlatamab administered IV with 1-step dosing: Dose A on cycle 1 day 1 followed by Dose B on cycle 1 day 8 and cycle 1 day 15, and Dose B Q2W thereafter. Each cycle was 28 days. Participants also received a fixed dose short-term infusion of AMG 404 every 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
40.0%
2/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
37.5%
3/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
25.0%
2/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
25.0%
2/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Cardiac disorders
Atrial fibrillation
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Eye disorders
Blindness
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Eye disorders
Cataract
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Eye disorders
Diplopia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
16.7%
1/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
60.0%
3/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
40.0%
2/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
40.0%
2/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
37.5%
3/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
25.0%
2/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
General disorders
Fatigue
|
42.9%
3/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
40.0%
2/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
25.0%
2/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
General disorders
Gait disturbance
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
General disorders
Pain
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
General disorders
Pyrexia
|
28.6%
2/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
60.0%
3/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Immune system disorders
Cytokine release syndrome
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
66.7%
2/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
62.5%
5/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
40.0%
2/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
Cystitis
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
25.0%
2/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
40.0%
2/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Investigations
Platelet count decreased
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Investigations
Weight decreased
|
28.6%
2/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
60.0%
3/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
57.1%
4/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
40.0%
2/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
25.0%
1/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
25.0%
2/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
40.0%
2/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
25.0%
2/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
40.0%
2/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
37.5%
3/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Metabolism and nutrition disorders
Weight loss poor
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Musculoskeletal and connective tissue disorders
Muscle mass
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Ataxia
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Brain fog
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Dizziness
|
28.6%
2/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Dysarthria
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Dysgeusia
|
42.9%
3/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
66.7%
2/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Encephalopathy
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
40.0%
2/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Immune effector cell-associated neurotoxicity syndrome
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Leukoencephalopathy
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Restless legs syndrome
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Tremor
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Psychiatric disorders
Agitation
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
40.0%
2/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
40.0%
2/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Psychiatric disorders
Insomnia
|
28.6%
2/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Renal and urinary disorders
Urinary tract discomfort
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Vascular disorders
Deep vein thrombosis
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
25.0%
1/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Eye disorders
Dry eye
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Eye disorders
Eye disorder
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Pancreatitis
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
25.0%
1/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
12.5%
1/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
33.3%
1/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Investigations
Blood prolactin abnormal
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
60.0%
3/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
25.0%
1/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/6 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
20.0%
1/5 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/3 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/1 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/4 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
0.00%
0/8 • For all-cause mortality, from enrollment to study completion; median time on study was 9.4 (0.4, 25.5) months. TEAEs were collected from first dose of IP up to last dose + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months. TEAEs for the EP were collected from 65 days up to 145 days or EOS after the last dose of tarlatamab or AMG 404; median (min, max) duration was 2.6 (0.6, 8.4) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER