Trial Outcomes & Findings for A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU) (NCT NCT03033511)
NCT ID: NCT03033511
Last Updated: 2021-07-29
Results Overview
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
748 participants
Primary outcome timeframe
Survival follow-up continued until the endpoint of death, participant was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.
Results posted on
2021-07-29
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo every 6 weeks (q6 wk); omitting every third cycle
Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
|
Rovalpituzumab Tesirine/Dexamethasone
Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle
Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
|
|---|---|---|
|
Overall Study
STARTED
|
376
|
372
|
|
Overall Study
COMPLETED
|
376
|
372
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
Baseline characteristics by cohort
| Measure |
Placebo
n=376 Participants
Placebo every 6 weeks (q6 wk); omitting every third cycle
Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
|
Rovalpituzumab Tesirine/Dexamethasone
n=372 Participants
Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle
Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
|
Total
n=748 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 8.20 • n=5 Participants
|
64.1 years
STANDARD_DEVIATION 8.40 • n=7 Participants
|
63.9 years
STANDARD_DEVIATION 8.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
239 Participants
n=5 Participants
|
258 Participants
n=7 Participants
|
497 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
356 Participants
n=5 Participants
|
355 Participants
n=7 Participants
|
711 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
301 Participants
n=5 Participants
|
314 Participants
n=7 Participants
|
615 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
66 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple Races
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Survival follow-up continued until the endpoint of death, participant was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.Population: DLL3 High Set: all randomized participants with extensive-stage small cell lung cancer with delta-like protein 3 high expression in tumor (DLL3high), defined as ≥ 75% tumor cells staining positive according to the VENTANA DLL3 \[SP347\] immunohistochemistry \[IHC\] assay.
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
Outcome measures
| Measure |
Placebo
n=240 Participants
Placebo every 6 weeks (q6 wk); omitting every third cycle
Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
|
Rovalpituzumab Tesirine/Dexamethasone
n=217 Participants
Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle
Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
|
|---|---|---|
|
Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)
|
9.79 months
Interval 8.38 to 10.87
|
8.48 months
Interval 7.26 to 10.18
|
SECONDARY outcome
Timeframe: Survival follow-up continued until the endpoint of death, the subject was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.Population: Randomized Set: all randomized participants, grouped according to the treatment arm to which they were randomized regardless the actual treatment received.
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
Outcome measures
| Measure |
Placebo
n=376 Participants
Placebo every 6 weeks (q6 wk); omitting every third cycle
Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
|
Rovalpituzumab Tesirine/Dexamethasone
n=372 Participants
Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle
Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
|
|---|---|---|
|
OS in All Randomized Participants
|
9.89 months
Interval 8.61 to 11.01
|
8.80 months
Interval 7.95 to 9.53
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)Population: Randomized Set: all randomized participants, grouped according to the treatment arm to which they were randomized regardless the actual treatment received. Participants with an assessment at given time point.
The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life.
Outcome measures
| Measure |
Placebo
n=376 Participants
Placebo every 6 weeks (q6 wk); omitting every third cycle
Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
|
Rovalpituzumab Tesirine/Dexamethasone
n=372 Participants
Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle
Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
|
|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Change at Week 6
|
-3.97 score on a scale
Standard Error 1.00
|
-4.34 score on a scale
Standard Error 0.95
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Change at Week 12
|
-1.70 score on a scale
Standard Error 1.67
|
-12.13 score on a scale
Standard Error 1.27
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Change at Week 18
|
8.15 score on a scale
Standard Error 4.02
|
-19.52 score on a scale
Standard Error 4.92
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Change at Week 24
|
-0.95 score on a scale
Standard Error 7.32
|
-19.39 score on a scale
Standard Error 6.61
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Change at Week 30
|
5.33 score on a scale
Standard Error 4.22
|
-16.67 score on a scale
Standard Error 6.78
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Change at Week 36
|
-13.33 score on a scale
Standard Error NA
Statistical model did not support SE estimation for a sample set that was \< 5 participants.
|
-13.33 score on a scale
Standard Error NA
Statistical model did not support SE estimation for a sample set that was \< 5 participants.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Change at Week 42
|
-6.67 score on a scale
Standard Error NA
Statistical model did not support SE estimation for a sample set that was \< 5 participants.
|
-3.33 score on a scale
Standard Error NA
Statistical model did not support SE estimation for a sample set that was \< 5 participants.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Change at Week 48
|
-6.67 score on a scale
Standard Error NA
Statistical model did not support SE estimation for a sample set that was \< 5 participants.
|
-63.33 score on a scale
Standard Error NA
Statistical model did not support SE estimation for a sample set that was \< 5 participants.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Change at Week 54
|
-6.67 score on a scale
Standard Error NA
Statistical model did not support SE estimation for a sample set that was \< 5 participants.
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Change at Week 60
|
0.00 score on a scale
Standard Error NA
Statistical model did not support SE estimation for a sample set that was \< 5 participants.
|
0.00 score on a scale
Standard Error NA
Statistical model did not support SE estimation for a sample set that was \< 5 participants.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Change at Week 66
|
0.00 score on a scale
Standard Error NA
Statistical model did not support SE estimation for a sample set that was \< 5 participants.
|
0.00 score on a scale
Standard Error NA
Statistical model did not support SE estimation for a sample set that was \< 5 participants.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Change at Week 72
|
0.00 score on a scale
Standard Error NA
Statistical model did not support SE estimation for a sample set that was \< 5 participants.
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Change at Week 78
|
0.00 score on a scale
Standard Error NA
Statistical model did not support SE estimation for a sample set that was \< 5 participants.
|
0.00 score on a scale
Standard Error NA
Statistical model did not support SE estimation for a sample set that was \< 5 participants.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Change at Week Final Visit
|
-4.14 score on a scale
Standard Error 1.02
|
-13.31 score on a scale
Standard Error 1.12
|
Adverse Events
Placebo
Serious events: 87 serious events
Other events: 248 other events
Deaths: 201 deaths
Rovalpituzumab Tesirine/Dexamethasone
Serious events: 157 serious events
Other events: 315 other events
Deaths: 226 deaths
Serious adverse events
| Measure |
Placebo
n=373 participants at risk
Placebo q6 wk; omitting every third cycle
Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
|
Rovalpituzumab Tesirine/Dexamethasone
n=368 participants at risk
Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle
Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.80%
3/373 • Number of events 3 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
2.2%
8/368 • Number of events 9 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.54%
2/373 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
1.1%
4/368 • Number of events 4 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Cardiac disorders
RIGHT VENTRICULAR FAILURE
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Endocrine disorders
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Eye disorders
ANGLE CLOSURE GLAUCOMA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Eye disorders
EYELID OEDEMA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Eye disorders
PERIORBITAL SWELLING
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
ABDOMINAL ADHESIONS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.54%
2/373 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
1.6%
6/368 • Number of events 6 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
DUODENAL OBSTRUCTION
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
GASTRIC PERFORATION
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.82%
3/368 • Number of events 4 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.54%
2/373 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
VOMITING
|
0.54%
2/373 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
ASTHENIA
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.82%
3/368 • Number of events 3 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
CHILLS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
DEATH
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
DISEASE PROGRESSION
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
EUTHANASIA
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
FACE OEDEMA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
FATIGUE
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 3 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
2.1%
8/373 • Number of events 10 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
2.4%
9/368 • Number of events 11 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
GENERALISED OEDEMA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
HYPOTHERMIA
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
MALAISE
|
0.54%
2/373 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
PYREXIA
|
0.54%
2/373 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
SEROSITIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
SWELLING FACE
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
DRUG-INDUCED LIVER INJURY
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
HEPATITIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
JAUNDICE CHOLESTATIC
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
LIVER DISORDER
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
BILIARY TRACT INFECTION
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
CAMPYLOBACTER GASTROENTERITIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
CORONA VIRUS INFECTION
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
CYTOMEGALOVIRUS CHORIORETINITIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
GANGRENE
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
HAEMOPHILUS INFECTION
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
KLEBSIELLA INFECTION
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.82%
3/368 • Number of events 3 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
LUNG ABSCESS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
METAPNEUMOVIRUS INFECTION
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
PNEUMONIA
|
2.1%
8/373 • Number of events 8 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
3.8%
14/368 • Number of events 16 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
PNEUMONIA PSEUDOMONAL
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
PSEUDOMONAS INFECTION
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.54%
2/373 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
RHINITIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
SEPSIS
|
0.54%
2/373 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
1.6%
6/368 • Number of events 8 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.82%
3/368 • Number of events 3 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
FALL
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
RADIATION PNEUMONITIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Investigations
BLOOD URIC ACID INCREASED
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.82%
3/368 • Number of events 4 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Investigations
PANCREATIC ENZYMES INCREASED
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.27%
1/373 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.27%
1/373 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.27%
1/373 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.82%
3/368 • Number of events 3 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
1.1%
4/368 • Number of events 4 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.82%
3/368 • Number of events 3 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
1.3%
5/373 • Number of events 6 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
1.6%
6/368 • Number of events 7 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
HYPOPROTEINAEMIA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
FIBROMYALGIA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
OSTEOLYSIS
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA GASTRIC
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INFECTED NEOPLASM
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION
|
5.6%
21/373 • Number of events 25 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
4.3%
16/368 • Number of events 17 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
1.9%
7/373 • Number of events 10 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
1.9%
7/368 • Number of events 8 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO MENINGES
|
0.27%
1/373 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM PROGRESSION
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEUROENDOCRINE CARCINOMA
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SINONASAL PAPILLOMA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL CARCINOMA
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL LUNG CANCER METASTATIC
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
BRAIN OEDEMA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
DYSMETRIA
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
EPILEPSY
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
FACIAL PARESIS
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
HYPERAESTHESIA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDER
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
PARAPLEGIA
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
SEIZURE
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
SYNCOPE
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
VOCAL CORD PARALYSIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.54%
2/373 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Renal and urinary disorders
DYSURIA
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.82%
3/368 • Number of events 4 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.54%
2/373 • Number of events 3 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL OBSTRUCTION
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.54%
2/373 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.1%
4/373 • Number of events 5 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
3.3%
12/368 • Number of events 14 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.54%
2/373 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
6.0%
22/368 • Number of events 23 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
1.9%
7/368 • Number of events 11 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY ARTERY THROMBOSIS
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 3 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
1.4%
5/368 • Number of events 7 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS BULLOUS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.82%
3/368 • Number of events 3 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Vascular disorders
JUGULAR VEIN THROMBOSIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Vascular disorders
SHOCK
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Vascular disorders
SUPERIOR VENA CAVA SYNDROME
|
0.80%
3/373 • Number of events 3 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.54%
2/368 • Number of events 2 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Vascular disorders
VASCULAR COMPRESSION
|
0.27%
1/373 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.00%
0/368 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Vascular disorders
VENA CAVA THROMBOSIS
|
0.00%
0/373 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
0.27%
1/368 • Number of events 1 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Placebo
n=373 participants at risk
Placebo q6 wk; omitting every third cycle
Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
|
Rovalpituzumab Tesirine/Dexamethasone
n=368 participants at risk
Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle
Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
|
|---|---|---|
|
Investigations
WEIGHT DECREASED
|
4.3%
16/373 • Number of events 17 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
5.2%
19/368 • Number of events 22 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.9%
11/373 • Number of events 18 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
12.2%
45/368 • Number of events 51 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
2.7%
10/373 • Number of events 11 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
8.4%
31/368 • Number of events 37 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
3.8%
14/373 • Number of events 19 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
16.6%
61/368 • Number of events 79 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
1.6%
6/373 • Number of events 7 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
15.8%
58/368 • Number of events 63 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
3.8%
14/373 • Number of events 14 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
5.7%
21/368 • Number of events 24 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
CONSTIPATION
|
9.4%
35/373 • Number of events 37 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
13.0%
48/368 • Number of events 57 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
DIARRHOEA
|
9.4%
35/373 • Number of events 39 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
8.2%
30/368 • Number of events 35 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
1.1%
4/373 • Number of events 4 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
5.4%
20/368 • Number of events 23 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
NAUSEA
|
13.7%
51/373 • Number of events 56 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
20.9%
77/368 • Number of events 86 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
VOMITING
|
9.4%
35/373 • Number of events 40 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
9.5%
35/368 • Number of events 41 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
ASTHENIA
|
6.7%
25/373 • Number of events 27 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
9.2%
34/368 • Number of events 48 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
FACE OEDEMA
|
1.3%
5/373 • Number of events 5 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
11.1%
41/368 • Number of events 48 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
FATIGUE
|
16.1%
60/373 • Number of events 66 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
24.7%
91/368 • Number of events 112 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
OEDEMA PERIPHERAL
|
7.5%
28/373 • Number of events 32 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
25.3%
93/368 • Number of events 134 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
General disorders
PYREXIA
|
3.2%
12/373 • Number of events 13 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
5.4%
20/368 • Number of events 24 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.1%
8/373 • Number of events 8 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
10.6%
39/368 • Number of events 45 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
3.2%
12/373 • Number of events 13 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
13.0%
48/368 • Number of events 59 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
1.6%
6/373 • Number of events 7 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
7.9%
29/368 • Number of events 44 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.80%
3/373 • Number of events 3 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
5.2%
19/368 • Number of events 21 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
13.1%
49/373 • Number of events 55 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
25.8%
95/368 • Number of events 115 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.80%
3/373 • Number of events 4 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
7.9%
29/368 • Number of events 32 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.80%
3/373 • Number of events 4 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
8.7%
32/368 • Number of events 41 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
2.4%
9/373 • Number of events 10 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
7.3%
27/368 • Number of events 34 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.1%
19/373 • Number of events 20 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
8.2%
30/368 • Number of events 33 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.8%
29/373 • Number of events 29 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
6.0%
22/368 • Number of events 23 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
DIZZINESS
|
4.8%
18/373 • Number of events 18 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
8.2%
30/368 • Number of events 34 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Nervous system disorders
HEADACHE
|
5.1%
19/373 • Number of events 19 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
8.4%
31/368 • Number of events 39 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Psychiatric disorders
INSOMNIA
|
3.5%
13/373 • Number of events 13 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
9.0%
33/368 • Number of events 33 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
11.5%
43/373 • Number of events 47 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
15.2%
56/368 • Number of events 69 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.5%
39/373 • Number of events 41 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
18.2%
67/368 • Number of events 83 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
2.9%
11/373 • Number of events 12 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
20.7%
76/368 • Number of events 98 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
2.9%
11/373 • Number of events 12 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
6.2%
23/368 • Number of events 27 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
2.4%
9/373 • Number of events 9 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
5.7%
21/368 • Number of events 21 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
1.3%
5/373 • Number of events 6 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
6.0%
22/368 • Number of events 38 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
1.3%
5/373 • Number of events 5 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
23.9%
88/368 • Number of events 128 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
4.6%
17/373 • Number of events 18 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
5.7%
21/368 • Number of events 25 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
RASH
|
2.1%
8/373 • Number of events 9 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
6.5%
24/368 • Number of events 30 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
SKIN TOXICITY
|
1.6%
6/373 • Number of events 6 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
6.0%
22/368 • Number of events 24 • All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER