Trial Outcomes & Findings for AMG 404 in Patients With Advanced Solid Tumors (NCT NCT03853109)
NCT ID: NCT03853109
Last Updated: 2025-07-20
Results Overview
Toxicities were graded with the Common Terminology Criteria for Adverse Events CTCAE v5.0., the following toxicities were classified as DLTs: * Any treatment related grade 5 toxicity * Grade 4 neutropenia or thrombocytopenia * Febrile neutropenia * Grade 4 anemia * Grade 3 or 4 non-hematologic toxicity * Recurrent grade 2 pneumonitis * Any other toxicity requiring permanent discontinuation of AMG 404.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
171 participants
Primary outcome timeframe
Up to Day 28
Results posted on
2025-07-20
Participant Flow
This study was conducted at 34 centers in Australia, Belgium, Brazil, Canada, Japan, Poland, Singapore, South Korea, Spain, Taiwan, Turkey, the United Kingdom, and the United States. Participants were recruited between 05 March 2019 and 02 November 2023.
Participants were screened for a period up to 28 days prior to Day 1, and then randomized to receive different doses of AMG 404. Cohort 5 was planned but it was never opened.
Participant milestones
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
9
|
21
|
21
|
20
|
42
|
42
|
13
|
|
Overall Study
Did Not Receive AMG 404
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
4
|
11
|
9
|
14
|
14
|
17
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
10
|
12
|
6
|
28
|
25
|
10
|
Reasons for withdrawal
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
2
|
1
|
4
|
5
|
3
|
|
Overall Study
Decision by Sponsor
|
0
|
0
|
1
|
0
|
1
|
1
|
10
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
3
|
0
|
0
|
|
Overall Study
Death
|
2
|
5
|
8
|
10
|
3
|
20
|
10
|
5
|
Baseline Characteristics
AMG 404 in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
n=3 Participants
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
n=9 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
n=21 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
n=21 Participants
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
n=20 Participants
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
n=42 Participants
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
n=42 Participants
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
n=13 Participants
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
59.3 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
60.1 years
STANDARD_DEVIATION 8.7 • n=21 Participants
|
59.5 years
STANDARD_DEVIATION 14.5 • n=8 Participants
|
62.5 years
STANDARD_DEVIATION 11.8 • n=8 Participants
|
64.6 years
STANDARD_DEVIATION 9.0 • n=24 Participants
|
60.7 years
STANDARD_DEVIATION 12.3 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
79 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
92 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
37 Participants
n=8 Participants
|
35 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
152 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
41 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black (or African American)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
113 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: The DLT analysis set included DLT evaluable participants who had completed the DLT window period of 28 days on AMG 404 treatment (starting cycle 1, day 1) or experienced a DLT any time during the DLT window or had received at least 90% of the planned dose of investigational product and was followed for at least 1 cycle. Only participants in cohort 1 to 4 were DLT-evaluable.
Toxicities were graded with the Common Terminology Criteria for Adverse Events CTCAE v5.0., the following toxicities were classified as DLTs: * Any treatment related grade 5 toxicity * Grade 4 neutropenia or thrombocytopenia * Febrile neutropenia * Grade 4 anemia * Grade 3 or 4 non-hematologic toxicity * Recurrent grade 2 pneumonitis * Any other toxicity requiring permanent discontinuation of AMG 404.
Outcome measures
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
n=3 Participants
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
n=7 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
n=4 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
n=13 Participants
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to the last dose of AMG 404 + 140 days (approximately 46 months); median (min, max) exposure to AMG 404 was 3.58 (0.02, 41.7) monthsPopulation: The safety analysis set consisted of all participants who received at least one dose of AMG 404.
A TEAE is any adverse event (AE) starting on or after the first administration of investigational product (IP) and up to and including 140 days after the last IP dose date or end of the study, whichever occurs earlier. A TEAE with unknown/missing relatedness to AMG 404 is assumed as an event is related to AMG 404. A serious adverse event (SAE) is defined as an adverse event that: is fatal, is life threatening, requires in-patient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and other medically important serious event. A treatment-related AE (TRAE) is any TEAE that per investigator review has a reasonable possibility of being caused by the investigational product. In the unlikely event that the relationship is missing, the TEAE will be considered TRAE and documented in a footnote of the treatment-related summary.
Outcome measures
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
n=3 Participants
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
n=9 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
n=20 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
n=21 Participants
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
n=20 Participants
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
n=41 Participants
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
n=41 Participants
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
n=13 Participants
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
All TEAEs
|
3 Participants
|
9 Participants
|
20 Participants
|
21 Participants
|
20 Participants
|
41 Participants
|
40 Participants
|
13 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Fatal AEs
|
1 Participants
|
4 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
15 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
SAEs
|
2 Participants
|
5 Participants
|
12 Participants
|
15 Participants
|
11 Participants
|
28 Participants
|
16 Participants
|
7 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
TRAEs
|
1 Participants
|
5 Participants
|
8 Participants
|
15 Participants
|
13 Participants
|
34 Participants
|
26 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, end of infusion (EOI), 2h, 4h post dose; Day 2; Day 4; Day 8; Day 15 of Cycle 1 and 2 (28 day cycle length)Population: The PK Analysis Set contained all participants who received at least 1 dose of AMG 404 and had at least 1 PK sample collected. These participants were evaluated for PK analysis unless the number of data points required for analysis was not enough, or significant protocol deviations affected the data, or if key dosing or sampling information was missing. Per SAP, cohorts have been combined by dose for reporting of PK data
Maximum concentration of AMG 404 in blood serum at different time points.
Outcome measures
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
n=3 Participants
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
n=126 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
n=21 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
|---|---|---|---|---|---|---|---|---|
|
AMG 404 Pharmacokinetic (PK) Parameter by Dose Group: Maximum Observed Serum Concentration (Cmax) During Cycle 1 and 2
Cycle 1
|
84 µg/mL
Geometric Coefficient of Variation 38
|
176 µg/mL
Geometric Coefficient of Variation 23
|
398 µg/mL
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
|
—
|
|
AMG 404 Pharmacokinetic (PK) Parameter by Dose Group: Maximum Observed Serum Concentration (Cmax) During Cycle 1 and 2
Cycle 2
|
96 µg/mL
Geometric Coefficient of Variation 39
|
203 µg/mL
Geometric Coefficient of Variation 33
|
485 µg/mL
Geometric Coefficient of Variation 50
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, end of infusion (EOI), 2h, 4h post dose; Day 2; Day 4; Day 8; Day 15 of Cycle 1 and 2 (28 day cycle length)Population: The PK Analysis Set contained all participants who received at least 1 dose of AMG 404 and had at least 1 PK sample collected. These participants were evaluated for PK analysis unless the number of data points required for analysis was not enough, or significant protocol deviations affected the data, or if key dosing or sampling information was missing. Per SAP, cohorts have been combined by dose for reporting of PK data
Tmax represents the time to reach Cmax in the blood serum.
Outcome measures
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
n=3 Participants
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
n=126 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
n=21 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
|---|---|---|---|---|---|---|---|---|
|
AMG 404 PK Parameter by Dose Group: Time to Achieve Cmax (Tmax) During Cycle 1 and 2
Cycle 1
|
0.550 Hour
Interval 0.55 to 0.667
|
0.783 Hour
Interval 0.317 to 25.3
|
2.50 Hour
Interval 0.533 to 72.6
|
—
|
—
|
—
|
—
|
—
|
|
AMG 404 PK Parameter by Dose Group: Time to Achieve Cmax (Tmax) During Cycle 1 and 2
Cycle 2
|
2.53 Hour
Interval 0.967 to 2.57
|
0.742 Hour
Interval 0.5 to 72.9
|
0.883 Hour
Interval 0.5 to 4.75
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, end of infusion (EOI), 2h, 4h post dose; Day 2; Day 4; Day 8; Day 15 of Cycle 1 and 2 (28 day cycle length)Population: The PK Analysis Set contained all participants who received at least 1 dose of AMG 404 and had at least 1 PK sample collected. These participants were evaluated for PK analysis unless the number of data points required for analysis was not enough, or significant protocol deviations affected the data, or if key dosing or sampling information was missing. Per SAP, cohorts have been combined by dose for reporting of PK data
Assessment of AMG 404 exposure over 28 days.
Outcome measures
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
n=3 Participants
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
n=126 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
n=21 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
|---|---|---|---|---|---|---|---|---|
|
AMG 404 PK Parameter by Dose Group: Area Under the Serum Concentration-time Curve From Day 0 to Day 28 (AUC0-28d) During Cycle 1 and 2
Cycle 1
|
732 day*µg/mL
Geometric Coefficient of Variation 40
|
1660 day*µg/mL
Geometric Coefficient of Variation 30
|
3800 day*µg/mL
Geometric Coefficient of Variation 31
|
—
|
—
|
—
|
—
|
—
|
|
AMG 404 PK Parameter by Dose Group: Area Under the Serum Concentration-time Curve From Day 0 to Day 28 (AUC0-28d) During Cycle 1 and 2
Cycle 2
|
1130 day*µg/mL
Geometric Coefficient of Variation 27
|
2240 day*µg/mL
Geometric Coefficient of Variation 33
|
4730 day*µg/mL
Geometric Coefficient of Variation 49
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and Day 15Population: The safety analysis set consisted of all participants who received at least one dose of AMG 404.
Transient was defined as the number of participants with negative result at the participant's last time point tested within the study period. Only participants with both baseline and post-baseline are included.
Outcome measures
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
n=3 Participants
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
n=9 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
n=20 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
n=21 Participants
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
n=20 Participants
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
n=41 Participants
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
n=41 Participants
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
n=13 Participants
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-AMG 404 Antibodies
Positive at anytime
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
11 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With Anti-AMG 404 Antibodies
Positive at or before baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Anti-AMG 404 Antibodies
Positive post-baseline and negative at baseline
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
11 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Anti-AMG 404 Antibodies
Transient
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 54 monthsPopulation: The safety analysis set consisted of all participants who received at least one dose of AMG 404.
Objective response was defined as a tumor response assessment of either complete response (CR) (disappearance of all target lesions) or partial response (PR) (at least a 30% decrease in the sum of the diameters of target lesions) measured by positron emission tomography(PET)/computed tomography (CT), CT or magnetic resonance imaging (MRI) and assessed per RECIST v1.1. Participants who did not experience PR/CR or did not have any follow-up tumor assessments was regarded as non-responders. This endpoint was determined only for participants with measurable disease at baseline.
Outcome measures
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
n=3 Participants
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
n=9 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
n=20 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
n=21 Participants
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
n=20 Participants
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
n=41 Participants
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
n=41 Participants
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
n=13 Participants
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
|---|---|---|---|---|---|---|---|---|
|
Objective Tumor Response Per Evaluation Criteria in Solid Tumours (RECIST) V1.1
|
0.0 Percentage of participants
Interval 0.0 to 53.58
|
0.0 Percentage of participants
Interval 0.0 to 22.57
|
5.0 Percentage of participants
Interval 0.53 to 18.1
|
4.8 Percentage of participants
Interval 0.5 to 17.29
|
25.0 Percentage of participants
Interval 12.69 to 41.49
|
17.1 Percentage of participants
Interval 9.76 to 27.04
|
36.6 Percentage of participants
Interval 26.44 to 47.78
|
30.8 Percentage of participants
Interval 14.16 to 52.34
|
SECONDARY outcome
Timeframe: Up to approximately 43 monthsPopulation: The safety analysis set included all participants who received at least one dose of AMG 404. The DOR analysis was conducted for participants who achieved an objective response (CR or PR) as determined by modified RECIST 1.1 criteria. Participants who did not achieve an objective response were not included in the DOR analysis, as DOR could not be calculated for these cases.
DOR was defined as the time from the first documentation of objective response (CR or PR) until the first documentation of disease progression or death due to any cause, whichever occurred first. Only participants who achieved objective response were evaluated for DOR. DOR was censored at the last evaluable post-baseline tumor assessment date; otherwise, at the first dose of IP. Kaplan-Meier (KM) analysis was used to estimate DOR for responders, providing a median value and 80% confidence intervals (CI) where sufficient data were available. The Brookmeyer and Crowley method was used to calculate confidence intervals. For cohorts with limited responders or heavily censored data, the median DOR or CI bounds could not be calculated.
Outcome measures
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
n=1 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
n=1 Participants
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
n=5 Participants
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
n=7 Participants
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
n=15 Participants
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
n=4 Participants
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) Per Modified RECIST v1.1
|
—
|
—
|
NA Months
Median and CI could not be calculated due to the low number of observations.
|
16.85 Months
The lower and upper CIs could not be calculated as only one participant had an OR and contributed to the DOR analysis.
|
NA Months
Interval 5.55 to
Median and upper CI could not be calculated due to the low number of observations.
|
11.07 Months
Interval 5.55 to 20.24
|
NA Months
Interval 25.76 to
Median and upper CI could not be calculated due to the low number of observations.
|
NA Months
Interval 2.66 to
Median and upper CI could not be calculated due to the low number of observations.
|
SECONDARY outcome
Timeframe: Up to approximately 54 monthsPopulation: The safety analysis set consisted of all participants who received at least one dose of AMG 404.
DCR was defined as the percentage of participants in whom objective response (CR or PR) or stable disease (SD) was determined as per RECIST v1.1.
Outcome measures
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
n=3 Participants
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
n=9 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
n=20 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
n=21 Participants
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
n=20 Participants
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
n=41 Participants
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
n=41 Participants
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
n=13 Participants
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR) Per Modified RECIST v1.1
|
33.3 Percentage of participants
Interval 3.45 to 80.42
|
44.4 Percentage of participants
Interval 21.04 to 69.9
|
35.0 Percentage of participants
Interval 20.67 to 51.8
|
42.9 Percentage of participants
Interval 27.78 to 59.05
|
55.0 Percentage of participants
Interval 38.48 to 70.71
|
48.8 Percentage of participants
Interval 37.81 to 59.85
|
70.7 Percentage of participants
Interval 59.76 to 80.07
|
76.9 Percentage of participants
Interval 55.57 to 91.2
|
SECONDARY outcome
Timeframe: Up to approximately 54 monthsPopulation: The analysis population consisted of participants who achieved a best overall response of SD per Modified RECIST v1.1 criteria. This analysis includes only participants from the safety analysis set who received at least one dose of AMG 404 and met the criteria for SD based on tumor assessments.
DoSD was measured from the start of treatment until the first documentation of disease progression or death due to any cause. DoSD was calculated only in participants with the best overall response of SD, defined as neither sufficient shrinkage to qualify PR nor sufficient increase to qualify for PD. KM analysis was used to estimate the median DoSD, and CIs were calculated using the Brookmeyer and Crowley method. DoSD was censored at the last evaluable post-baseline tumor assessment date or at the first dose of IP, if no progression or death was documented.
Outcome measures
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
n=1 Participants
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
n=4 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
n=6 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
n=8 Participants
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
n=6 Participants
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
n=13 Participants
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
n=14 Participants
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
n=6 Participants
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Stable Disease (DoSD) Per Modified RECIST v1.1
|
5.36 Months
The lower and upper confidence intervals could not be calculated because only one participant had a best overall response of SD and contributed to the DoSD analysis. Additionally, there were not enough events at later times to estimate an upper bound.
|
5.54 Months
Interval 3.65 to
Upper CI could not be calculated due to the low number of observations. Additionally, there were not enough events at later times to estimate an upper bound.
|
6.54 Months
Interval 3.55 to 7.26
|
5.59 Months
Interval 4.11 to
Upper CI could not be calculated due to the low number of observations. Additionally, there were not enough events at later times to estimate an upper bound.
|
4.62 Months
Interval 3.61 to 9.46
|
5.55 Months
Interval 4.3 to 5.59
|
16.56 Months
Interval 9.03 to
Upper CI could not be calculated due to the low number of observations. Additionally, there were not enough events at later times to estimate an upper bound.
|
3.55 Months
Interval 2.23 to 9.66
|
SECONDARY outcome
Timeframe: Up to approximately 48 monthsPopulation: The safety analysis set consisted of all participants who received at least one dose of AMG 404.
PFS was defined as the time from the first dose of IP unite the first documentation of radiological disease progression or death due to any cause, whichever occurred first in the absence of subsequent anticancer therapy.
Outcome measures
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
n=3 Participants
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
n=9 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
n=20 Participants
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
n=21 Participants
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
n=20 Participants
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
n=41 Participants
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
n=41 Participants
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
n=13 Participants
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) Per Modified RECIST v1.1
|
2.89 Months
Interval 1.48 to
Upper CI could not be calculated due to the low number of observations.
|
1.84 Months
Interval 1.41 to 3.71
|
1.89 Months
Interval 1.84 to 3.55
|
1.84 Months
Interval 1.68 to 4.5
|
3.68 Months
Interval 2.53 to 9.46
|
3.06 Months
Interval 1.87 to 4.3
|
16.56 Months
Interval 9.03 to 29.24
|
4.37 Months
Interval 2.23 to 14.98
|
Adverse Events
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
Serious events: 5 serious events
Other events: 9 other events
Deaths: 5 deaths
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
Serious events: 12 serious events
Other events: 20 other events
Deaths: 8 deaths
Cohort 4: Dose Exploration AMG 404 Dose C (High)
Serious events: 15 serious events
Other events: 20 other events
Deaths: 10 deaths
Cohort 6: Dose Expansion AMG 404 RP2D
Serious events: 11 serious events
Other events: 20 other events
Deaths: 3 deaths
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
Serious events: 28 serious events
Other events: 41 other events
Deaths: 20 deaths
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
Serious events: 16 serious events
Other events: 39 other events
Deaths: 10 deaths
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
Serious events: 7 serious events
Other events: 12 other events
Deaths: 5 deaths
Overall Subjects
Serious events: 96 serious events
Other events: 164 other events
Deaths: 63 deaths
Serious adverse events
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
n=3 participants at risk
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
n=9 participants at risk
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
n=20 participants at risk
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
n=21 participants at risk
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
n=20 participants at risk
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
n=41 participants at risk
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
n=41 participants at risk
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
n=13 participants at risk
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
Overall Subjects
n=168 participants at risk
Overall Subjects
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer metastatic
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Porocarcinoma
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular germ cell tumour
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymic carcinoma
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of the renal pelvis and ureter
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Endocrine disorders
Addison's disease
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Malignant ascites
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Death
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Disease progression
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Malaise
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Sudden death
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.4%
2/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Hepatobiliary disorders
Hepatic necrosis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Abscess
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.3%
3/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.0%
5/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Injury, poisoning and procedural complications
Skin graft failure
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Injury, poisoning and procedural complications
Wound haematoma
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer stage IV
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dedifferentiated liposarcoma
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratinising squamous cell carcinoma of nasopharynx
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant fibrous histiocytoma
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of thymus
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant sweat gland neoplasm
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Undifferentiated sarcoma
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.0%
5/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Product Issues
Device occlusion
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Skin and subcutaneous tissue disorders
Severe cutaneous adverse reaction
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
Other adverse events
| Measure |
Cohort 1: Dose Escalation AMG 404 Dose A (Low)
n=3 participants at risk
Participants received AMG 404 Dose A administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 2: Dose Escalation AMG 404 Dose B (Mid)
n=9 participants at risk
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 3: Dose Expansion AMG 404 Dose B (Mid)
n=20 participants at risk
Participants received AMG 404 Dose B administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 4: Dose Exploration AMG 404 Dose C (High)
n=21 participants at risk
Participants received AMG 404 Dose C administered as an IV injection. This cohort contributed to identifying the RP2D.
|
Cohort 6: Dose Expansion AMG 404 RP2D
n=20 participants at risk
Participants received AMG 404 at the RP2D (Dose B).
|
Cohort 7: AMG 404 RP2D Tumor Specific Efficacy
n=41 participants at risk
Participants affected by various types of specific tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 8: AMG 404 RP2D Tumor Specific Efficacy
n=41 participants at risk
Participants affected by MSI-high and dMMR types of tumors received AMG 404 at the RP2D (Dose B).
|
Cohort 9: AMG 404 RP2D Tumor Specific Efficacy
n=13 participants at risk
Participants affected by PD-L1 positive non-small cell lung cancer with a TPS ≥ 50% received AMG 404 at the RP2D (Dose B).
|
Overall Subjects
n=168 participants at risk
Overall Subjects
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pyuria
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.0%
5/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.0%
5/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.5%
2/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
17.1%
7/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.5%
16/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
20.0%
4/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.3%
3/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
25.0%
5/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
17.1%
7/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.6%
6/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.4%
2/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
17.3%
29/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.2%
7/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Endocrine disorders
Addison's disease
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
8/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.3%
3/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.8%
4/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.8%
4/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.5%
16/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Eye disorders
Photophobia
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.6%
6/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.0%
5/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.8%
4/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.4%
9/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
25.0%
5/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
19.0%
4/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.0%
3/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
12.2%
5/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
12.5%
21/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.0%
5/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.3%
3/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
12.2%
5/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
6.5%
11/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
19.0%
4/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
20.0%
4/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
22.0%
9/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
22.0%
9/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
23.1%
3/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
19.6%
33/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
22.2%
2/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
30.0%
6/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
25.0%
5/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.8%
4/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
29.3%
12/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
18.5%
31/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.0%
5/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.5%
2/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.6%
6/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.0%
5/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.5%
2/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.0%
5/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
55.6%
5/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
35.0%
7/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
23.8%
5/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
35.0%
7/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
22.0%
9/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
31.7%
13/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
29.2%
49/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.4%
2/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.0%
5/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
44.4%
4/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.5%
2/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
30.0%
6/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
17.1%
7/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.8%
4/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.5%
26/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.2%
7/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
12.2%
5/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.4%
9/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Chills
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Disease progression
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
44.4%
4/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
30.0%
6/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
33.3%
7/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
35.0%
7/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
34.1%
14/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
43.9%
18/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.4%
2/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
35.7%
60/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Hernia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Malaise
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.5%
2/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.6%
6/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Oedema
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
12.2%
5/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.1%
12/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.6%
6/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
20.0%
4/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.3%
3/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.0%
3/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
19.5%
8/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.6%
6/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
38.5%
5/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
17.9%
30/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
29.3%
12/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
23.1%
3/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.7%
18/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.5%
2/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.6%
6/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
22.2%
2/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.0%
3/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.6%
6/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.5%
16/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.8%
4/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
8/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.4%
2/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
6.5%
11/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
20.0%
4/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.8%
4/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.4%
2/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
8.9%
15/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
8/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.6%
6/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.5%
2/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.5%
2/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
6.5%
11/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Investigations
Weight increased
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
22.2%
2/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
20.0%
4/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
38.1%
8/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
25.0%
5/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
22.0%
9/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
19.5%
8/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
30.8%
4/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
24.4%
41/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.6%
6/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.5%
2/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.0%
3/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.4%
9/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.5%
2/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.4%
9/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.3%
3/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
20.0%
4/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
24.4%
10/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
24.4%
10/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
17.3%
29/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.5%
2/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.6%
6/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
24.4%
10/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
12.5%
21/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
8/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.3%
3/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.6%
6/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
12.2%
5/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
8.9%
15/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.8%
4/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.6%
6/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.0%
3/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
17.1%
7/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
8.9%
15/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.3%
3/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
12.2%
5/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
12.2%
5/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
8.9%
15/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.0%
5/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Product Issues
Device occlusion
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.0%
5/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Psychiatric disorders
Confusional state
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.8%
4/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
8/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.3%
3/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
17.1%
7/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.4%
2/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.7%
18/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.0%
5/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.8%
4/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.8%
4/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.0%
3/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
12.2%
5/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
8.9%
15/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.4%
2/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
22.2%
2/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.0%
3/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
22.0%
9/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.9%
20/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.4%
2/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.5%
2/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.2%
7/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.2%
7/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
4/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.0%
5/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
19.0%
4/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
9.8%
4/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
26.8%
11/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.4%
2/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
13.7%
23/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
11.1%
1/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.3%
3/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
10.0%
2/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
19.5%
8/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
14.6%
6/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
15.4%
2/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
13.7%
23/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
12.2%
5/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.4%
9/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.2%
2/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.3%
3/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.2%
7/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.9%
2/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
3.0%
5/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
5.0%
1/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
4.8%
1/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
2.4%
1/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
1.8%
3/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/3 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/9 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/21 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/20 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.00%
0/41 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
7.7%
1/13 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
0.60%
1/168 • Up to approximately 54 months
All-cause mortality was collected for all enrolled participants; AE/SAE was collected for all participants who received at least 1 dose of AMG 404.
|
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