Trial Outcomes & Findings for A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (NCT NCT04740034)
NCT ID: NCT04740034
Last Updated: 2025-06-17
Results Overview
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. A treatment-related AE (TRAE) was defined as any TEAE flagged as possibly caused by AMG 340. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious TEAEs (SAEs) were any untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months
Results posted on
2025-06-17
Participant Flow
Participants with progressive metastatic castrate-resistant prostate carcinoma (mCRPC) participated in the study from April 2021 to June 2024, and were enrolled across 6 sites in the United States.
The study was designed to consist of two parts: a monotherapy dose escalation (Part A) and a monotherapy dose expansion (Part B). For strategic reasons, the study was terminated before enrollment into Part B could begin. Dose A is the lowest dose, Dose I is the highest dose.
Participant milestones
| Measure |
Cohort 1: AMG 340 Dose A
Participants with progressive mCRPC received AMG 340 Dose A administered as an intravenous (IV) infusion every 3 week (Q3W) in 21-day cycles.
|
Cohort 2: AMG 340 Dose B
Participants with progressive mCRPC received AMG 340 Dose B administered as an IV infusion Q3W in 21-day cycles.
|
Cohort 3: AMG 340 Dose C
Participants with progressive mCRPC received AMG 340 Dose C administered as an IV infusion Q3W every 21-day cycle.
|
Cohort 4: AMG 340 Dose D
Participants with progressive mCRPC received AMG 340 Dose D administered as an IV infusion Q3W in 21-day cycles.
|
Cohort 5: AMG 340 Dose E
Participants with progressive mCRPC received AMG 340 Dose E administered as an IV infusion Q3W in 21-day cycles.
|
Cohort 6a: AMG 340 Priming Dose (PmD) (High) and Then AMG 340 Dose E
Participants with progressive mCRPC received AMG 340 (high) PmD on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
3
|
5
|
6
|
6
|
3
|
5
|
3
|
7
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
4
|
6
|
6
|
3
|
5
|
3
|
7
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1: AMG 340 Dose A
Participants with progressive mCRPC received AMG 340 Dose A administered as an intravenous (IV) infusion every 3 week (Q3W) in 21-day cycles.
|
Cohort 2: AMG 340 Dose B
Participants with progressive mCRPC received AMG 340 Dose B administered as an IV infusion Q3W in 21-day cycles.
|
Cohort 3: AMG 340 Dose C
Participants with progressive mCRPC received AMG 340 Dose C administered as an IV infusion Q3W every 21-day cycle.
|
Cohort 4: AMG 340 Dose D
Participants with progressive mCRPC received AMG 340 Dose D administered as an IV infusion Q3W in 21-day cycles.
|
Cohort 5: AMG 340 Dose E
Participants with progressive mCRPC received AMG 340 Dose E administered as an IV infusion Q3W in 21-day cycles.
|
Cohort 6a: AMG 340 Priming Dose (PmD) (High) and Then AMG 340 Dose E
Participants with progressive mCRPC received AMG 340 (high) PmD on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
2
|
3
|
4
|
4
|
2
|
2
|
2
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
2
|
2
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Decision by sponsor
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
2
|
1
|
1
|
2
|
Baseline Characteristics
A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
Baseline characteristics by cohort
| Measure |
Cohort 1: Dose A
n=1 Participants
Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).
|
Cohort 2: Dose B
n=1 Participants
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=3 Participants
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=5 Participants
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=6 Participants
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=6 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=5 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=7 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
78.0 Years
STANDARD_DEVIATION NA • n=5 Participants
|
54.0 Years
STANDARD_DEVIATION NA • n=7 Participants
|
69.0 Years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
67.6 Years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
71.8 Years
STANDARD_DEVIATION 9.2 • n=21 Participants
|
59.2 Years
STANDARD_DEVIATION 6.4 • n=8 Participants
|
75.7 Years
STANDARD_DEVIATION 9.0 • n=8 Participants
|
70.8 Years
STANDARD_DEVIATION 5.2 • n=24 Participants
|
67.0 Years
STANDARD_DEVIATION 2.6 • n=42 Participants
|
69.9 Years
STANDARD_DEVIATION 4.5 • n=42 Participants
|
71.0 Years
STANDARD_DEVIATION 12.7 • n=42 Participants
|
68.5 Years
STANDARD_DEVIATION 7.8 • n=42 Participants
|
|
Sex: Female, Male
Female
|
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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
42 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
41 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
38 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) monthsPopulation: SAS: All participants who received at least 1 dose of AMG 340.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. A treatment-related AE (TRAE) was defined as any TEAE flagged as possibly caused by AMG 340. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious TEAEs (SAEs) were any untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events.
Outcome measures
| Measure |
Cohort 1: Dose A
n=1 Participants
Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).
|
Cohort 2: Dose B
n=1 Participants
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=3 Participants
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=5 Participants
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=6 Participants
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=6 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=5 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=7 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
All TEAEs
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
All SAEs
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
All TRAEs
|
0 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to approximately Day 21Population: DLT evaluable analysis set: All participants who were evaluable for DLTs. A participants was considered DLT evaluable if the participant completed at least the first full treatment cycle or experienced a DLT during the first treatment cycle.
A DLT was defined as a TEAE that was not unequivocally due to the participant's underlying malignancy or other extraneous cause, and appeared within 21 days from the first dose of AMG 340. AEs considered DLTs were: * Transient (≤72 hours) grade 3 or 4 electrolyte abnormalities, hyperglycemia, nausea/vomiting/diarrhea responsive to treatment. * Alopecia, vitiligo, and grade 3 fatigue lasting \<10 days. * Grade 3 fever lasting ≤24 hours (outside CRS context). * Grade 3 lab abnormalities resolving within 72 hours (or within 7 days for certain enzymes like ALT, GGT, ALP, and lipase). * Grade 3 CRS or TLS unresolved to ≤ grade 1 within 72 hours or any grade 4 CRS/TLS. * Prolonged grade 4 neutropenia (\>5 days) or febrile neutropenia. * Grade 3 thrombocytopenia with bleeding or any grade 4 thrombocytopenia. * Grade 4 anemia. * Grade 5 adverse events. * Lymphopenia is not considered a DLT.
Outcome measures
| Measure |
Cohort 1: Dose A
n=1 Participants
Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).
|
Cohort 2: Dose B
n=1 Participants
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=2 Participants
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=5 Participants
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=5 Participants
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=6 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=5 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=6 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Cohorts 1-5: Days 1 (pre-dose to 6 hours post-dose), 2, 3, 8, and 10; Cohorts 6-10: Days 1 (pre-dose to 6 hours post-dose), 2, 3, 5 (pre-dose to 6 hours post-dose), 6, 7, 8 (pre-dose to 6 hours post-dose), 9, 10Population: PK analysis set: Included all participants who received at least 1 dose of AMG 340 and had at least 1 PK sample drawn post dose. Summary statistics are presented per dose level as pre-specified in SAP Section 9.7.
Blood samples for pharmacokinetics (PK) analysis were collected at specific time points. PK parameters were estimated using standard non-compartmental approaches.
Outcome measures
| Measure |
Cohort 1: Dose A
n=1 Participants
Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).
|
Cohort 2: Dose B
n=1 Participants
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=3 Participants
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=5 Participants
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=6 Participants
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=9 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=5 Participants
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Median Concentration of AMG 340
|
0.352 µg/mL
Interval 0.352 to 0.352
|
0.818 µg/mL
Interval 0.818 to 0.818
|
2.445 µg/mL
Interval 0.233 to 4.71
|
6.78 µg/mL
Interval 0.661 to 16.2
|
17.8 µg/mL
Interval 0.116 to 54.5
|
19.25 µg/mL
Interval 0.0 to 52.3
|
54.4 µg/mL
Interval 3.61 to 129.0
|
68.0 µg/mL
Interval 17.1 to 149.0
|
75.2 µg/mL
Interval 2.64 to 201.0
|
201 µg/mL
Interval 79.1 to 397.0
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: RECIST 1.1 Evaluable Analysis Set: All participants who have received at least 1 dose of AMG 340, had measurable disease per RECIST 1.1 at baseline, and had the opportunity to be followed for at least 6 weeks from start of AMG 340 treatment.
OR was defined as a partial response (PR) or complete response (CR) per RECIST 1.1, confirmed by a repeat assessment at least 4 weeks later. Participants who did not experience a confirmed PR/CR or did not have any follow-up tumor assessments were regarded as non-responders.
Outcome measures
| Measure |
Cohort 1: Dose A
Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).
|
Cohort 2: Dose B
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=3 Participants
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=2 Participants
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=4 Participants
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=4 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=5 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
—
|
—
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
0 Percentage of Participants
Interval 0.0 to 60.24
|
0 Percentage of Participants
Interval 0.0 to 60.24
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
0 Percentage of Participants
Interval 0.0 to 70.76
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
0 Percentage of Participants
Interval 0.0 to 52.18
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: SAS: All participants who received at least 1 dose of AMG 340.
OS was defined as the time from the date of study Day 1 until death due to any cause.
Outcome measures
| Measure |
Cohort 1: Dose A
n=1 Participants
Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).
|
Cohort 2: Dose B
n=1 Participants
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=3 Participants
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=5 Participants
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=6 Participants
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=6 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=5 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=7 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
9.2 Months
Interval 9.2 to 9.2
|
13.4 Months
Interval 13.4 to 13.4
|
10.22 Months
Interval 4.8 to 12.2
|
11.56 Months
Interval 3.4 to 20.3
|
5.59 Months
Interval 1.6 to 19.2
|
8.15 Months
Interval 3.1 to 19.3
|
5.45 Months
Interval 4.2 to 25.7
|
NA Months
Interval 3.0 to 28.2
Median could not be calculated as there was an insufficient number of participants with events.
|
6.97 Months
Interval 1.5 to 27.1
|
7.56 Months
Interval 0.5 to 15.4
|
NA Months
Interval 8.5 to 10.6
Median could not be calculated as there was an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: SAS: All participants who received at least 1 dose of AMG 340.
PSA PFS was defined as the interval from study day 1 to the earlier of a PSA progression or death from any cause; otherwise, PSA PFS was censored on the date of the last PSA measurement. If a participant had no baseline or post-baseline PSA measurement and a vital status of alive or unknown, PSA PFS was censored at study day 1.
Outcome measures
| Measure |
Cohort 1: Dose A
n=1 Participants
Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).
|
Cohort 2: Dose B
n=1 Participants
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=3 Participants
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=5 Participants
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=6 Participants
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=6 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=5 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=7 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Prostate Specific Antigen (PSA) Progression Free Survival (PFS)
|
1.4 Months
Interval 1.4 to 1.4
|
2.1 Months
Interval 2.1 to 2.1
|
4.83 Months
Interval 3.4 to 6.9
|
3.20 Months
Interval 2.1 to 6.2
|
2.89 Months
Interval 1.5 to 8.3
|
3.12 Months
Interval 1.9 to 8.1
|
2.8 Months
Interval 2.8 to 5.5
|
3.48 Months
Interval 0.0 to 3.8
|
6.97 Months
Interval 1.5 to 27.1
|
4.86 Months
Interval 0.0 to 9.4
|
NA Months
Interval 1.4 to 1.9
Median could not be calculated as there was an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: SAS: All participants who received at least 1 dose of AMG 340.
rPFS was defined as the interval from study day 1 to radiographic progression or death from any cause, whichever occurred first, in the absence of subsequent anti-cancer therapy; otherwise, rPFS was censored at the last evaluable tumor assessment date prior to subsequent anti-cancer therapy. If a participant had no post-baseline radiographic tumor assessment and a vital status of alive or unknown, rPFS was censored at study day 1.
Outcome measures
| Measure |
Cohort 1: Dose A
n=1 Participants
Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).
|
Cohort 2: Dose B
n=1 Participants
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=3 Participants
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=5 Participants
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=6 Participants
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=6 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=5 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=7 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Radiographic PFS (rPFS)
|
NA Months
Interval 7.8 to 7.8
Median could not be calculated as there was an insufficient number of participants with events.
|
3.48 Months
Interval 3.48 to 3.48
|
5.32 Months
Interval 1.4 to 7.2
|
3.38 Months
Interval 1.2 to 3.4
|
1.56 Months
Interval 1.4 to 6.2
|
2.25 Months
Interval 0.9 to 9.4
|
4.27 Months
Interval 1.2 to 5.5
|
3.84 Months
Interval 1.4 to 7.5
|
1.31 Months
Interval 1.2 to 11.7
|
2.35 Months
Interval 0.0 to 13.6
|
NA Months
Interval 1.9 to 3.9
Median could not be calculated as there was an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: SAS: All participants who received at least 1 dose of AMG 340.
rPFS was defined as the interval from study day 1 to radiographic progression or death from any cause, whichever occurred first, in the absence of subsequent anti-cancer therapy; otherwise, rPFS was censored at the last evaluable tumor assessment date prior to subsequent anti-cancer therapy. If a participant had no post-baseline radiographic tumor assessment and a vital status of alive or unknown, rPFS was censored at study day 1.
Outcome measures
| Measure |
Cohort 1: Dose A
n=1 Participants
Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).
|
Cohort 2: Dose B
n=1 Participants
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=3 Participants
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=5 Participants
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=6 Participants
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=6 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=5 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=7 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With rPFS at 6 Months
|
100.0 Percentage of participants
95% Confidence interval (CI) not estimable due to the low number of participants in the analysis population.
|
0.0 Percentage of participants
95% CI not estimable due to the low number of participants in the analysis population.
|
33.3 Percentage of participants
Interval 0.9 to 77.4
|
0.0 Percentage of participants
95% CI could not be calculated as there was an insufficient number of participants with events.
|
33.3 Percentage of participants
Interval 4.6 to 67.6
|
16.7 Percentage of participants
Interval 0.8 to 51.7
|
0.0 Percentage of participants
95% CI not estimable due to the low number of participants in the analysis population.
|
33.3 Percentage of participants
Interval 0.9 to 77.4
|
33.3 Percentage of participants
Interval 0.9 to 77.4
|
16.7 Percentage of participants
Interval 0.8 to 51.7
|
NA Percentage of participants
Median and 95% CI not estimable due to the low number of participants in the analysis population.
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: The PSA response evaluable analysis set was defined as all participants who received at least one dose of AMG 340, had a measurable (i.e., \> 0) PSA at baseline, and had the opportunity to be followed for at least nine weeks from the start of AMG 340 treatment. Participants who stopped disease assessments prior to nine weeks were included in this analysis set if the data snapshot date was at least nine weeks after their first study dose date.
PSA 30 was defined as a ≥ 30% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later.
Outcome measures
| Measure |
Cohort 1: Dose A
n=1 Participants
Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).
|
Cohort 2: Dose B
n=1 Participants
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=3 Participants
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=5 Participants
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=6 Participants
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=6 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=5 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=7 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a 30% Reduction From Baseline in PSA (PSA30)
|
0.0 Percentage of Participants
Interval 0.0 to 97.5
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
33.3 Percentage of Participants
Interval 0.84 to 90.57
|
20.0 Percentage of Participants
Interval 0.51 to 71.64
|
0.0 Percentage of Participants
Interval 0.0 to 45.93
|
16.7 Percentage of Participants
Interval 0.42 to 64.12
|
0.0 Percentage of Participants
Interval 0.0 to 70.76
|
20.0 Percentage of Participants
Interval 0.51 to 71.64
|
33.3 Percentage of Participants
Interval 0.84 to 90.57
|
0.0 Percentage of Participants
Interval 0.0 to 40.96
|
0.0 Percentage of Participants
Interval 0.0 to 84.19
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: The PSA response evaluable analysis set was defined as all participants who received at least one dose of AMG 340, had a measurable (i.e., \> 0) PSA at baseline, and had the opportunity to be followed for at least nine weeks from the start of AMG 340 treatment. Participants who stopped disease assessments prior to nine weeks were included in this analysis set if the data snapshot date was at least nine weeks after their first study dose date.
PSA 50 was defined as a ≥ 50% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later.
Outcome measures
| Measure |
Cohort 1: Dose A
n=1 Participants
Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).
|
Cohort 2: Dose B
n=1 Participants
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=3 Participants
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=5 Participants
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=6 Participants
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=6 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=5 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=7 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a 50% Reduction From Baseline in PSA (PSA50)
|
0.0 Percentage of Participants
Interval 0.0 to 97.5
|
100.0 Percentage of Participants
Interval 2.5 to 100.0
|
33.3 Percentage of Participants
Interval 0.84 to 90.57
|
20.0 Percentage of Participants
Interval 0.51 to 71.64
|
0.0 Percentage of Participants
Interval 0.0 to 45.93
|
16.7 Percentage of Participants
Interval 0.42 to 64.12
|
0.0 Percentage of Participants
Interval 0.0 to 70.76
|
0.0 Percentage of Participants
Interval 0.0 to 52.18
|
0.0 Percentage of Participants
Interval 0.0 to 70.76
|
0.0 Percentage of Participants
Interval 0.0 to 40.96
|
0.0 Percentage of Participants
Interval 0.0 to 84.19
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: The PSA response evaluable analysis set was defined as all participants who received at least one dose of AMG 340, had a measurable (i.e., \> 0) PSA at baseline, and had the opportunity to be followed for at least nine weeks from the start of AMG 340 treatment. Participants who stopped disease assessments prior to nine weeks were included in this analysis set if the data snapshot date was at least nine weeks after their first study dose date.
PSA 70 was defined as a ≥ 70% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later.
Outcome measures
| Measure |
Cohort 1: Dose A
n=1 Participants
Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).
|
Cohort 2: Dose B
n=1 Participants
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=3 Participants
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=5 Participants
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=6 Participants
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=6 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=5 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=7 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a 70% Reduction From Baseline in PSA (PSA70)
|
0.0 Percentage of Participants
Interval 0.0 to 97.5
|
0.0 Percentage of Participants
Interval 0.0 to 97.5
|
0.0 Percentage of Participants
Interval 0.0 to 70.76
|
0.0 Percentage of Participants
Interval 0.0 to 52.18
|
0.0 Percentage of Participants
Interval 0.0 to 45.93
|
0.0 Percentage of Participants
Interval 0.0 to 45.93
|
0.0 Percentage of Participants
Interval 0.0 to 70.76
|
0.0 Percentage of Participants
Interval 0.0 to 52.18
|
0.0 Percentage of Participants
Interval 0.0 to 70.76
|
0.0 Percentage of Participants
Interval 0.0 to 40.96
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: The PSA response evaluable analysis set was defined as all participants who received at least one dose of AMG 340, had a measurable (i.e., \> 0) PSA at baseline, and had the opportunity to be followed for at least nine weeks from the start of AMG 340 treatment. Participants who stopped disease assessments prior to nine weeks were included in this analysis set if the data snapshot date was at least nine weeks after their first study dose date.
PSA 90 was defined as a ≥ 90% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later.
Outcome measures
| Measure |
Cohort 1: Dose A
n=1 Participants
Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).
|
Cohort 2: Dose B
n=1 Participants
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=3 Participants
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=5 Participants
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=6 Participants
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=6 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=5 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=7 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a 90% Reduction From Baseline in PSA (PSA90)
|
0.0 Percentage of Participants
Interval 0.0 to 97.5
|
0.0 Percentage of Participants
Interval 0.0 to 97.5
|
0.0 Percentage of Participants
Interval 0.0 to 70.76
|
0.0 Percentage of Participants
Interval 0.0 to 52.18
|
0.0 Percentage of Participants
Interval 0.0 to 45.93
|
0.0 Percentage of Participants
Interval 0.0 to 45.93
|
0.0 Percentage of Participants
Interval 0.0 to 70.76
|
0.0 Percentage of Participants
Interval 0.0 to 52.18
|
0.0 Percentage of Participants
Interval 0.0 to 70.76
|
0.0 Percentage of Participants
Interval 0.0 to 40.96
|
0.0 Percentage of Participants
Interval 0.0 to 84.19
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: RECIST 1.1 Evaluable Analysis Set: All participants who received at least one dose of AMG 340, had measurable disease per RECIST 1.1 at baseline, and had the opportunity to be followed for at least six weeks from the start of AMG 340 treatment. Participants who stopped disease assessments prior to six weeks were included in this analysis set if the data snapshot date was at least six weeks after their first study dose date.
DOR was defined as the time from the date of an initial objective response per RECIST 1.1, which was subsequently confirmed, until soft-tissue progression per RECIST 1.1 or death, whichever occurred first in the absence of subsequent anti-cancer therapy. Participants who had not ended their response at the time of analysis had DOR censored at their last evaluable tumor assessment by CT/MRI scan prior to subsequent anti-cancer therapy. This endpoint only applied to participants with an objective response (CR or PR) per RECIST 1.1. No participants achieved CR or PR, therefore, no participants could be analyzed for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: SAS: All participants who received at least 1 dose of AMG 340.
SSE was defined as time from study day 1 to the first symptomatic skeletal event, otherwise time to symptomatic skeletal event was censored at the last dose of AMG 340 or end of safety follow-up date, whichever was later.
Outcome measures
| Measure |
Cohort 1: Dose A
n=1 Participants
Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).
|
Cohort 2: Dose B
n=1 Participants
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=3 Participants
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=5 Participants
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=6 Participants
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=6 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=5 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=3 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=7 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
n=2 Participants
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Symptomatic Skeletal Events (SSE)
|
0 Number of Participants
|
0 Number of Participants
|
1 Number of Participants
|
1 Number of Participants
|
2 Number of Participants
|
2 Number of Participants
|
0 Number of Participants
|
1 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
Adverse Events
Cohort 1: Dose A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: Dose B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Cohort 3: Dose C
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort 4: Dose D
Serious events: 3 serious events
Other events: 5 other events
Deaths: 3 deaths
Cohort 5: Dose E
Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
Serious events: 1 serious events
Other events: 5 other events
Deaths: 2 deaths
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
Serious events: 4 serious events
Other events: 7 other events
Deaths: 4 deaths
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Dose A
n=1 participants at risk
Participants with progressive mCRPC received Dose A of AMG 340 administered as an IV infusion Q3W.
|
Cohort 2: Dose B
n=1 participants at risk
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=3 participants at risk
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=5 participants at risk
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=6 participants at risk
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=6 participants at risk
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=3 participants at risk
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=5 participants at risk
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=3 participants at risk
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=7 participants at risk
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
n=2 participants at risk
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
General disorders
Pain
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
42.9%
3/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Infections and infestations
Brain abscess
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
Other adverse events
| Measure |
Cohort 1: Dose A
n=1 participants at risk
Participants with progressive mCRPC received Dose A of AMG 340 administered as an IV infusion Q3W.
|
Cohort 2: Dose B
n=1 participants at risk
Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.
|
Cohort 3: Dose C
n=3 participants at risk
Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.
|
Cohort 4: Dose D
n=5 participants at risk
Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.
|
Cohort 5: Dose E
n=6 participants at risk
Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.
|
Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E
n=6 participants at risk
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E
n=3 participants at risk
Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F
n=5 participants at risk
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G
n=3 participants at risk
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H
n=7 participants at risk
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I
n=2 participants at risk
Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.
Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
1/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
42.9%
3/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
1/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
66.7%
2/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
3/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
66.7%
2/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
66.7%
2/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Eye disorders
Diplopia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Eye disorders
Eye pain
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Eye disorders
Visual impairment
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
1/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
66.7%
2/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
80.0%
4/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
3/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
60.0%
3/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
28.6%
2/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
1/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
80.0%
4/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
66.7%
4/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
80.0%
4/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
66.7%
2/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
28.6%
2/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
1/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
60.0%
3/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
66.7%
4/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
3/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
60.0%
3/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
42.9%
3/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
100.0%
2/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
General disorders
Chills
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
1/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
66.7%
2/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
80.0%
4/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
71.4%
5/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
1/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
General disorders
Pain
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
3/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
1/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
66.7%
4/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
66.7%
2/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
100.0%
3/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
57.1%
4/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
100.0%
2/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Infections and infestations
Candida infection
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Infections and infestations
Impetigo
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
100.0%
1/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
60.0%
3/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
100.0%
1/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
100.0%
3/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
57.1%
4/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
100.0%
2/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
100.0%
3/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
57.1%
4/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
1/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
60.0%
3/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
28.6%
2/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
3/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
28.6%
2/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
100.0%
1/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
3/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
66.7%
2/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
42.9%
3/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
3/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
1/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
60.0%
3/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
3/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
66.7%
2/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
1/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
28.6%
2/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
3/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
3/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
1/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Nervous system disorders
Syncope
|
100.0%
1/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
1/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
1/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
100.0%
2/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Psychiatric disorders
Depression
|
100.0%
1/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
66.7%
2/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Reproductive system and breast disorders
Genital pain
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
20.0%
1/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
40.0%
2/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
1/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
100.0%
2/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Social circumstances
Ex-tobacco user
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/1 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
66.7%
2/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
33.3%
2/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
16.7%
1/6 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/5 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
0.00%
0/3 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
14.3%
1/7 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
50.0%
1/2 • Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
|
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