Trial Outcomes & Findings for Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE) (NCT NCT03061812)
NCT ID: NCT03061812
Last Updated: 2021-02-23
Results Overview
OS is defined as the time from the date of randomization to the date of death from any cause. Participants were censored at the last date they were documented alive. After the End of treatment, survival information was collected at approximately 6-week intervals (or as requested by sponsor to support data analysis) continuing until the endpoint of death, the participant became lost to follow-up, AbbVie terminated the study, or until 12 February 2020. Calculated using the Kaplan-Meier product-limit method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
444 participants
Primary outcome timeframe
From randomization until the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.
Results posted on
2021-02-23
Participant Flow
Participant milestones
| Measure |
Topotecan
Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m\^2 on Days 1 to 5 of each 21-day cycle.
|
Rovalpituzumab Tesirine
Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted.
Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered.
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
296
|
|
Overall Study
COMPLETED
|
148
|
296
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)
Baseline characteristics by cohort
| Measure |
Topotecan
n=148 Participants
Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m\^2 on Days 1 to 5 of each 21-day cycle.
|
Rovalpituzumab Tesirine
n=296 Participants
Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted.
Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered.
|
Total
n=444 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 8.72 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 8.57 • n=7 Participants
|
63.1 years
STANDARD_DEVIATION 8.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
146 Participants
n=5 Participants
|
287 Participants
n=7 Participants
|
433 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
358 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization until the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.Population: Randomized participants
OS is defined as the time from the date of randomization to the date of death from any cause. Participants were censored at the last date they were documented alive. After the End of treatment, survival information was collected at approximately 6-week intervals (or as requested by sponsor to support data analysis) continuing until the endpoint of death, the participant became lost to follow-up, AbbVie terminated the study, or until 12 February 2020. Calculated using the Kaplan-Meier product-limit method.
Outcome measures
| Measure |
Topotecan
n=148 Participants
Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m\^2 on Days 1 to 5 of each 21-day cycle.
|
Rovalpituzumab Tesirine
n=296 Participants
Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted.
Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered.
|
|---|---|---|
|
Overall Survival (OS)
|
8.57 months
Interval 7.69 to 10.12
|
6.34 months
Interval 5.55 to 7.33
|
SECONDARY outcome
Timeframe: From randomization until the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.Population: Randomized participants
PFS is defined as the number of months from the date of randomization until the date of first progression or the date of a participant's death, whichever occurs first. If a participant neither experienced disease progression nor died, then the participant's data were censored at the last date of radiographic assessment that they were documented to be progression free. Calculated using the Kaplan-Meier product-limit method. Radiographic tumor assessments for response were conducted by CT scanning according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Progressive Disease (PD) was defined as at least a 20% increase in the size of target lesions and an absolute increase of at least 5 mm taking as reference the smallest lesion size recorded since the treatment started (baseline or after), or the appearance of one or more new lesions.
Outcome measures
| Measure |
Topotecan
n=148 Participants
Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m\^2 on Days 1 to 5 of each 21-day cycle.
|
Rovalpituzumab Tesirine
n=296 Participants
Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted.
Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
4.27 months
Interval 3.75 to 5.42
|
3.02 months
Interval 2.86 to 3.61
|
SECONDARY outcome
Timeframe: Baseline, Week 7Population: Randomized participants with an assessment at baseline and Week 7.
The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC core quality of life questionnaire (EORTC QLQ-C30) developed for use in palliative care. The score of 'physical functioning scale' score ranges from 0 (very poor) to 100 (excellent).
Outcome measures
| Measure |
Topotecan
n=93 Participants
Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m\^2 on Days 1 to 5 of each 21-day cycle.
|
Rovalpituzumab Tesirine
n=217 Participants
Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted.
Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered.
|
|---|---|---|
|
Change From Baseline of the Physical Functioning Scale Score in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC QLQ-C15-PAL) at Week 7
|
-7.16 score on a scale
Interval -11.95 to -2.36
|
-7.66 score on a scale
Interval -11.31 to -4.01
|
SECONDARY outcome
Timeframe: Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.Population: Randomized participants with measurable disease at baseline.
ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST version 1.1. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR or PR, including those who did not have post-baseline radiological assessments were considered non-responders. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Topotecan
n=129 Participants
Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m\^2 on Days 1 to 5 of each 21-day cycle.
|
Rovalpituzumab Tesirine
n=287 Participants
Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted.
Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
20.9 percentage of participants
Interval 14.27 to 28.97
|
14.6 percentage of participants
Interval 10.75 to 19.26
|
SECONDARY outcome
Timeframe: Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.Population: Randomized participants with measurable disease at baseline.
CBR is defined as percentage of participants whose best overall response is CR, PR, or stable disease (SD) according to RECIST version 1.1. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR, PR, or SD, including those who did not have post-baseline radiological assessments were considered as experiencing no clinical benefit. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Topotecan
n=129 Participants
Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m\^2 on Days 1 to 5 of each 21-day cycle.
|
Rovalpituzumab Tesirine
n=287 Participants
Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted.
Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered.
|
|---|---|---|
|
Clinical Benefit Rate (CBR)
|
43.4 percentage of participants
Interval 34.71 to 52.42
|
35.9 percentage of participants
Interval 30.34 to 41.74
|
SECONDARY outcome
Timeframe: Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.Population: Randomized participants with measurable disease at baseline, and a response.
DOR is defined as the time between the date of first response (CR or PR, whichever is recorded first) to the date of the first documented tumor progression (per RECIST version 1.1) or death due to any cause, whichever comes first. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR or PR, including those who did not have post-baseline radiological assessments were considered non-responders. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Topotecan
n=27 Participants
Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m\^2 on Days 1 to 5 of each 21-day cycle.
|
Rovalpituzumab Tesirine
n=42 Participants
Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted.
Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered.
|
|---|---|---|
|
Duration of Objective Response (DOR)
|
4.86 months
Interval 3.94 to 7.85
|
3.52 months
Interval 2.76 to 4.17
|
Adverse Events
Topotecan
Serious events: 74 serious events
Other events: 118 other events
Deaths: 115 deaths
Rovalpituzumab Tesirine
Serious events: 160 serious events
Other events: 245 other events
Deaths: 262 deaths
Serious adverse events
| Measure |
Topotecan
n=129 participants at risk
Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m\^2 on Days 1 to 5 of each 21-day cycle.
|
Rovalpituzumab Tesirine
n=287 participants at risk
Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted.
Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
3.1%
4/129 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.4%
4/287 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
8.5%
11/129 • Number of events 13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.4%
4/287 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
HAEMATOTOXICITY
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
4.7%
6/129 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
1.6%
2/129 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
7.8%
10/129 • Number of events 10 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.7%
5/287 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.0%
3/287 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Congenital, familial and genetic disorders
APLASIA
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.4%
4/287 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.0%
3/287 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
GASTRIC HAEMORRHAGE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.0%
3/287 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
SUBILEUS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
VOMITING
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
ASTHENIA
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
CHEST PAIN
|
1.6%
2/129 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
DEATH
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
DISEASE PROGRESSION
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
FACE OEDEMA
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
FATIGUE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
2.1%
6/287 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
4.7%
6/129 • Number of events 7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
2.8%
8/287 • Number of events 10 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
MALAISE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
POLYSEROSITIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
PYREXIA
|
2.3%
3/129 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
SEROSITIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
CHOLESTASIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
DRUG-INDUCED LIVER INJURY
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
JAUNDICE CHOLESTATIC
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
ABSCESS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
ATYPICAL PNEUMONIA
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
BRONCHITIS
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
CANDIDA INFECTION
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
GASTROENTERITIS
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
INFLUENZA
|
1.6%
2/129 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.7%
5/287 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
LUNG ABSCESS
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
ORCHITIS
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
PERITONITIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
PNEUMONIA
|
4.7%
6/129 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
6.6%
19/287 • Number of events 26 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
PNEUMONIA NECROTISING
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
PNEUMONIA STAPHYLOCOCCAL
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.0%
3/287 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
SALMONELLOSIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
SEPSIS
|
1.6%
2/129 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
EYELID CONTUSION
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
FALL
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
HEAT STROKE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
CULTURE URINE POSITIVE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
GENERAL PHYSICAL CONDITION ABNORMAL
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
LIPASE INCREASED
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
2.3%
3/129 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.0%
3/287 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL NEOPLASM
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INFECTED NEOPLASM
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM OF SPINAL CORD
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION
|
13.2%
17/129 • Number of events 19 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
10.5%
30/287 • Number of events 32 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO MENINGES
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM PROGRESSION
|
1.6%
2/129 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL LUNG CANCER
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL LUNG CANCER METASTATIC
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR NECROSIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
ATAXIA
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
CERVICAL CORD COMPRESSION
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
EMBOLIC STROKE
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
GENERALISED TONIC-CLONIC SEIZURE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
HEADACHE
|
1.6%
2/129 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
INTRACRANIAL PRESSURE INCREASED
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
INTRAVENTRICULAR HAEMORRHAGE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDER
|
0.78%
1/129 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
SYNCOPE
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
1.6%
2/129 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE LUNG INJURY
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.4%
4/287 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC RESPIRATORY FAILURE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
5.6%
16/287 • Number of events 20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA AT REST
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
1.6%
2/129 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
5.9%
17/287 • Number of events 17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.0%
3/287 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.0%
3/287 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HAEMORRHAGE
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.4%
4/287 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.0%
3/287 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
SHOCK HAEMORRHAGIC
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
SUPERIOR VENA CAVA SYNDROME
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.70%
2/287 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Topotecan
n=129 participants at risk
Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m\^2 on Days 1 to 5 of each 21-day cycle.
|
Rovalpituzumab Tesirine
n=287 participants at risk
Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted.
Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
58.1%
75/129 • Number of events 136 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
14.6%
42/287 • Number of events 53 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
19.4%
25/129 • Number of events 80 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.4%
4/287 • Number of events 8 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
38.8%
50/129 • Number of events 136 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
4.9%
14/287 • Number of events 20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
34.9%
45/129 • Number of events 94 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
13.6%
39/287 • Number of events 75 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
2.3%
3/129 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
19.5%
56/287 • Number of events 58 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
8.5%
11/129 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
7.3%
21/287 • Number of events 25 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
22.5%
29/129 • Number of events 36 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
11.5%
33/287 • Number of events 35 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
19.4%
25/129 • Number of events 29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
7.0%
20/287 • Number of events 24 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
31.0%
40/129 • Number of events 58 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
22.6%
65/287 • Number of events 77 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
VOMITING
|
13.2%
17/129 • Number of events 20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
10.5%
30/287 • Number of events 35 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
ASTHENIA
|
16.3%
21/129 • Number of events 28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
12.5%
36/287 • Number of events 47 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
CHEST PAIN
|
3.1%
4/129 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
6.3%
18/287 • Number of events 19 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
FATIGUE
|
27.1%
35/129 • Number of events 47 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
22.6%
65/287 • Number of events 85 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
OEDEMA PERIPHERAL
|
8.5%
11/129 • Number of events 14 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
17.8%
51/287 • Number of events 58 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
PYREXIA
|
4.7%
6/129 • Number of events 9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
5.6%
16/287 • Number of events 18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.2%
8/129 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
4.5%
13/287 • Number of events 13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.78%
1/129 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
6.3%
18/287 • Number of events 31 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
2.3%
3/129 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
7.0%
20/287 • Number of events 34 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
9.3%
12/129 • Number of events 20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.35%
1/287 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
PLATELET COUNT DECREASED
|
5.4%
7/129 • Number of events 13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
3.1%
9/287 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
WEIGHT DECREASED
|
5.4%
7/129 • Number of events 7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
6.3%
18/287 • Number of events 22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
27.1%
35/129 • Number of events 47 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
24.7%
71/287 • Number of events 87 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
2.3%
3/129 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
5.9%
17/287 • Number of events 18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
10.1%
13/129 • Number of events 13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
6.3%
18/287 • Number of events 24 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.8%
10/129 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
5.6%
16/287 • Number of events 19 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
9.3%
12/129 • Number of events 12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
7.3%
21/287 • Number of events 22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
5.4%
7/129 • Number of events 7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
2.4%
7/287 • Number of events 8 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
DYSGEUSIA
|
5.4%
7/129 • Number of events 8 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
2.1%
6/287 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
HEADACHE
|
8.5%
11/129 • Number of events 14 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
7.0%
20/287 • Number of events 21 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
PARAESTHESIA
|
5.4%
7/129 • Number of events 7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
0.00%
0/287 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
INSOMNIA
|
7.0%
9/129 • Number of events 9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
5.2%
15/287 • Number of events 17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
12.4%
16/129 • Number of events 19 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
14.6%
42/287 • Number of events 45 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
19.4%
25/129 • Number of events 28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
19.5%
56/287 • Number of events 69 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
10.9%
14/129 • Number of events 16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
3.1%
9/287 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
3.9%
5/129 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
22.6%
65/287 • Number of events 72 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
15.5%
20/129 • Number of events 24 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
1.0%
3/287 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
5.6%
16/287 • Number of events 22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
0.00%
0/129 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
16.0%
46/287 • Number of events 60 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.78%
1/129 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
8.7%
25/287 • Number of events 34 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
HYPOTENSION
|
3.1%
4/129 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
5.6%
16/287 • Number of events 16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
|
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