Trial Outcomes & Findings for Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). (NCT NCT04303780)
NCT ID: NCT04303780
Last Updated: 2025-10-14
Results Overview
PFS was defined as the time from randomization (baseline) until disease progression or death from any cause, whichever occurred first for all participants. Progression was based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). As pre-specified in the statistical analysis plan, for participants who crossed over from docetaxel to AMG 510, the participant's response post first progression or post crossover was not used for the primary analyses. Data are presented per original treatment randomized.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
345 participants
Primary outcome timeframe
Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 months
Results posted on
2025-10-14
Participant Flow
345 participants were enrolled at 148 centers in Europe, North America, Asia, Australia, and South America. The analyses presented in this results summary are based on the primary completion data. The primary completion data cut-off was 02 August 2022. The study is ongoing.
Screening assessments were conducted within 28 days before Cycle 1 Day 1 (C1D1; where a cycle is 21 days). Participants were then randomized 1:1 to receive either AMG 510 or docetaxel, stratified by number of prior lines of therapy in advanced disease (1 vs 2 vs \> 2), race (Asian vs non-Asian), and history of central nervous system (CNS) involvement (present or absent).
Participant milestones
| Measure |
AMG 510
Participants with previously treated locally advanced and unresectable or metastatic non small cell lung cancer (NSCLC) with centrally confirmed Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation received 960 mg of AMG 510 orally via tablets once a day (QD) in each 21 day cycle.
|
Docetaxel
Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m\^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).
|
|---|---|---|
|
Overall Study
STARTED
|
171
|
174
|
|
Overall Study
Switched From Docetaxel to AMG 510
|
0
|
46
|
|
Overall Study
COMPLETED
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
171
|
171
|
Reasons for withdrawal
| Measure |
AMG 510
Participants with previously treated locally advanced and unresectable or metastatic non small cell lung cancer (NSCLC) with centrally confirmed Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation received 960 mg of AMG 510 orally via tablets once a day (QD) in each 21 day cycle.
|
Docetaxel
Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m\^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).
|
|---|---|---|
|
Overall Study
Death
|
104
|
85
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
12
|
39
|
|
Overall Study
Ongoing in study
|
50
|
45
|
Baseline Characteristics
Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
Baseline characteristics by cohort
| Measure |
AMG 510
n=171 Participants
Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 960 mg of AMG 510 orally via tablets QD in each 21 day cycle.
|
Docetaxel
n=174 Participants
Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m\^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).
|
Total
n=345 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
63.5 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
165 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
328 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
142 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
286 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 monthsPopulation: Measured in the Full Analysis Set (FAS), which included all randomized participants.
PFS was defined as the time from randomization (baseline) until disease progression or death from any cause, whichever occurred first for all participants. Progression was based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). As pre-specified in the statistical analysis plan, for participants who crossed over from docetaxel to AMG 510, the participant's response post first progression or post crossover was not used for the primary analyses. Data are presented per original treatment randomized.
Outcome measures
| Measure |
AMG 510
n=171 Participants
Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 960 mg of AMG 510 orally via tablets QD in each 21 day cycle.
|
Docetaxel
n=174 Participants
Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m\^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).
|
|---|---|---|
|
Progression-free Survival (PFS)
|
5.62 months
Interval 4.27 to 7.75
|
4.47 months
Interval 3.02 to 5.68
|
Adverse Events
Docetaxel
Serious events: 67 serious events
Other events: 129 other events
Deaths: 78 deaths
AMG 510
Serious events: 91 serious events
Other events: 151 other events
Deaths: 109 deaths
Docetaxel, Then Switched to AMG 510
Serious events: 26 serious events
Other events: 35 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Docetaxel
n=151 participants at risk
Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m\^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).
|
AMG 510
n=169 participants at risk
Participants with previously treated locally advanced and unresectable or metastatic non small cell lung cancer (NSCLC) with centrally confirmed Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation received 960 mg of AMG 510 orally via tablets once a day (QD) in each 21 day cycle.
|
Docetaxel, Then Switched to AMG 510
n=46 participants at risk
Participants who were randomized to originally receive docetaxel, who were determined to have radiological progression according to RECIST v1.1 by the investigator and progressive disease confirmed by independent central imaging review, and switched to receive AMG 510. Alternatively, participants could switch from docetaxel to receive AMG 510 if an early efficacy of the study is noted by the data monitoring committee.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
5/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.6%
7/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Cardiac disorders
Cardiac arrest
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Cardiac disorders
Pericarditis
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Endocrine disorders
Adrenal cortex necrosis
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.8%
3/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
2/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
3.0%
5/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Ileus
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Nausea
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.3%
2/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Stomatitis
|
1.3%
2/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Asthenia
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Chest pain
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.8%
3/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Fatigue
|
1.3%
2/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
General physical health deterioration
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Malaise
|
1.3%
2/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Oedema peripheral
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Pain
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Pyrexia
|
1.3%
2/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.8%
3/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Immune system disorders
Anaphylactic reaction
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Atypical pneumonia
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Bacterial diarrhoea
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
COVID-19
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Cellulitis
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Infection
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Neutropenic sepsis
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.3%
2/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Pneumonia
|
6.6%
10/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.3%
2/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Pneumonia aspiration
|
1.3%
2/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Pneumonia bacterial
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Pneumonia legionella
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Pulmonary sepsis
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Sepsis
|
2.0%
3/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Skin infection
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Injury, poisoning and procedural complications
Fall
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Investigations
General physical condition abnormal
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Investigations
Liver function test increased
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Investigations
Neutrophil count decreased
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.3%
2/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
3.3%
5/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
10.7%
18/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
19.6%
9/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer recurrent
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour hyperprogression
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Altered state of consciousness
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Aphasia
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Loss of consciousness
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Seizure
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Thrombotic stroke
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
4/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.3%
2/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.3%
2/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Paraneoplastic pleural effusion
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
2/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
2/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
2/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.6%
4/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Skin and subcutaneous tissue disorders
Mucocutaneous rash
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Vascular disorders
Hypotension
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Vascular disorders
Intermittent claudication
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
Other adverse events
| Measure |
Docetaxel
n=151 participants at risk
Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m\^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).
|
AMG 510
n=169 participants at risk
Participants with previously treated locally advanced and unresectable or metastatic non small cell lung cancer (NSCLC) with centrally confirmed Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation received 960 mg of AMG 510 orally via tablets once a day (QD) in each 21 day cycle.
|
Docetaxel, Then Switched to AMG 510
n=46 participants at risk
Participants who were randomized to originally receive docetaxel, who were determined to have radiological progression according to RECIST v1.1 by the investigator and progressive disease confirmed by independent central imaging review, and switched to receive AMG 510. Alternatively, participants could switch from docetaxel to receive AMG 510 if an early efficacy of the study is noted by the data monitoring committee.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.9%
30/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
16.6%
28/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
10.9%
5/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.3%
14/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.8%
3/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.3%
2/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.0%
9/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
11.8%
20/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
6.5%
3/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
5/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
6.5%
11/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
6.5%
3/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Constipation
|
19.2%
29/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
13.0%
22/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
6.5%
3/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.5%
37/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
41.4%
70/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
30.4%
14/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Nausea
|
23.8%
36/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
25.4%
43/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
13.0%
6/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Stomatitis
|
12.6%
19/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.8%
3/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Gastrointestinal disorders
Vomiting
|
9.9%
15/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
13.0%
22/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.3%
2/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Asthenia
|
13.9%
21/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
9.5%
16/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
8.7%
4/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Chest pain
|
1.3%
2/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
7.1%
12/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.3%
2/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Fatigue
|
28.5%
43/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
16.0%
27/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
13.0%
6/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Malaise
|
6.0%
9/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.4%
4/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Mucosal inflammation
|
7.3%
11/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Oedema
|
5.3%
8/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.8%
3/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Oedema peripheral
|
12.6%
19/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.4%
4/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.3%
2/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Pain
|
6.0%
9/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
3.6%
6/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.3%
2/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
General disorders
Pyrexia
|
11.9%
18/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.7%
8/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Infections and infestations
COVID-19
|
3.3%
5/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
10.9%
5/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Investigations
Alanine aminotransferase increased
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
10.1%
17/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
8.7%
4/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Investigations
Aspartate aminotransferase increased
|
0.66%
1/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
10.1%
17/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
6.5%
3/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.0%
3/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
7.7%
13/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
6.5%
3/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Investigations
Weight decreased
|
4.6%
7/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
5.3%
9/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.3%
2/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.2%
29/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
23.1%
39/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
10.9%
5/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.3%
8/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.4%
4/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.6%
4/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
7.1%
12/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
6.5%
3/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.3%
8/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
3.0%
5/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.9%
21/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
15.4%
26/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
8.7%
4/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.6%
16/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
13.6%
23/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
8.7%
4/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
3/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
5.3%
9/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.3%
8/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.2%
2/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.9%
15/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.7%
8/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.2%
1/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
8/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
6.5%
11/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.3%
2/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Dizziness
|
4.6%
7/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
5.9%
10/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
6.5%
3/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Dysgeusia
|
9.3%
14/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
2.4%
4/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Headache
|
8.6%
13/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
7.1%
12/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.3%
2/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.6%
16/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.59%
1/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Psychiatric disorders
Insomnia
|
5.3%
8/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
5.3%
9/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.3%
2/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.6%
25/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
13.0%
22/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
8.7%
4/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.6%
25/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
17.8%
30/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
10.9%
5/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.2%
35/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
1.8%
3/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
0.00%
0/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.6%
7/151 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
8.9%
15/169 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
4.3%
2/46 • Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
|
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