Trial Outcomes & Findings for Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread (NCT NCT04527991)
NCT ID: NCT04527991
Last Updated: 2026-06-02
Results Overview
OS was defined as time from the date of randomization to the date of death, regardless of cause. Kaplan-Meier (KM) estimates were used for analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
711 participants
Primary outcome timeframe
Up to 42 months
Results posted on
2026-06-02
Participant Flow
Participants were enrolled at study sites in Asia, Australia, Europe, and North America.
886 participants were screened.
Participant milestones
| Measure |
Sacituzumab Govitecan-hziy (SG)
Participants received SG 10 mg/kg intravenously (IV) on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Overall Study
STARTED
|
355
|
356
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
355
|
356
|
Reasons for withdrawal
| Measure |
Sacituzumab Govitecan-hziy (SG)
Participants received SG 10 mg/kg intravenously (IV) on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Overall Study
Death
|
293
|
297
|
|
Overall Study
Other (Not Specified)
|
37
|
31
|
|
Overall Study
Withdrawal of Consent
|
21
|
27
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
Baseline Characteristics
Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
Baseline characteristics by cohort
| Measure |
Treatment of Physician's Choice
n=356 Participants
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
Total
n=711 Participants
Total of all reporting groups
|
Sacituzumab Govitecan-hziy (SG)
n=355 Participants
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
131 Participants
n=27 Participants
|
264 Participants
n=267 Participants
|
133 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
225 Participants
n=27 Participants
|
447 Participants
n=267 Participants
|
222 Participants
n=9 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 10.1 • n=27 Participants
|
67 years
STANDARD_DEVIATION 9.6 • n=267 Participants
|
66 years
STANDARD_DEVIATION 9.1 • n=9 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=27 Participants
|
148 Participants
n=267 Participants
|
71 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
279 Participants
n=27 Participants
|
563 Participants
n=267 Participants
|
284 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
82 Participants
n=27 Participants
|
174 Participants
n=267 Participants
|
92 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
188 Participants
n=27 Participants
|
382 Participants
n=267 Participants
|
194 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · Other or More Than One Race
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
1 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · Not Collected
|
83 Participants
n=27 Participants
|
151 Participants
n=267 Participants
|
68 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
271 Participants
n=27 Participants
|
550 Participants
n=267 Participants
|
279 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
6 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
8 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Collected
|
79 Participants
n=27 Participants
|
147 Participants
n=267 Participants
|
68 Participants
n=9 Participants
|
|
Region of Enrollment
France
|
81 Participants
n=27 Participants
|
150 Participants
n=267 Participants
|
69 Participants
n=9 Participants
|
|
Region of Enrollment
Spain
|
52 Participants
n=27 Participants
|
88 Participants
n=267 Participants
|
36 Participants
n=9 Participants
|
|
Region of Enrollment
China
|
41 Participants
n=27 Participants
|
83 Participants
n=267 Participants
|
42 Participants
n=9 Participants
|
|
Region of Enrollment
South Korea
|
27 Participants
n=27 Participants
|
65 Participants
n=267 Participants
|
38 Participants
n=9 Participants
|
|
Region of Enrollment
United Kingdom
|
28 Participants
n=27 Participants
|
55 Participants
n=267 Participants
|
27 Participants
n=9 Participants
|
|
Region of Enrollment
Italy
|
25 Participants
n=27 Participants
|
47 Participants
n=267 Participants
|
22 Participants
n=9 Participants
|
|
Region of Enrollment
Belgium
|
22 Participants
n=27 Participants
|
42 Participants
n=267 Participants
|
20 Participants
n=9 Participants
|
|
Region of Enrollment
Greece
|
14 Participants
n=27 Participants
|
30 Participants
n=267 Participants
|
16 Participants
n=9 Participants
|
|
Region of Enrollment
Australia
|
11 Participants
n=27 Participants
|
28 Participants
n=267 Participants
|
17 Participants
n=9 Participants
|
|
Region of Enrollment
Germany
|
13 Participants
n=27 Participants
|
26 Participants
n=267 Participants
|
13 Participants
n=9 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=27 Participants
|
19 Participants
n=267 Participants
|
14 Participants
n=9 Participants
|
|
Region of Enrollment
Austria
|
5 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
6 Participants
n=9 Participants
|
|
Region of Enrollment
Taiwan
|
7 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
3 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
6 Participants
n=9 Participants
|
|
Region of Enrollment
Georgia
|
6 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
3 Participants
n=9 Participants
|
|
Region of Enrollment
Israel
|
3 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
6 Participants
n=9 Participants
|
|
Region of Enrollment
Portugal
|
3 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
4 Participants
n=9 Participants
|
|
Region of Enrollment
Singapore
|
1 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
4 Participants
n=9 Participants
|
|
Region of Enrollment
Sweden
|
3 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
2 Participants
n=9 Participants
|
|
Region of Enrollment
Ireland
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
1 Participants
n=9 Participants
|
|
Region of Enrollment
Bulgaria
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
Croatia
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
1 Participants
n=9 Participants
|
|
Region of Enrollment
Switzerland
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
2 Participants
n=9 Participants
|
|
Region of Enrollment
Turkey
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
2 Participants
n=9 Participants
|
|
Region of Enrollment
Hong Kong
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Up to 42 monthsPopulation: Participants in the Intent-to-treat (ITT) Analysis Set were analyzed. The ITT Analysis Set included all participants who have been randomized to the trial.
OS was defined as time from the date of randomization to the date of death, regardless of cause. Kaplan-Meier (KM) estimates were used for analysis.
Outcome measures
| Measure |
Sacituzumab Govitecan-hziy (SG)
n=355 Participants
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
n=356 Participants
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Overall Survival (OS)
|
10.3 months
Interval 9.1 to 11.8
|
9.0 months
Interval 7.5 to 9.7
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Participants in the ITT Analysis Set were analyzed.
PFS was defined as the time from the date of randomization to the date of the first objectively documented disease progression (PD), per response evaluation criteria in solid tumors (RECIST) v1.1 criteria as determined by investigator assessment, or death regardless of cause, whichever occurs first. PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). KM estimates were used for analysis.
Outcome measures
| Measure |
Sacituzumab Govitecan-hziy (SG)
n=355 Participants
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
n=356 Participants
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Progression-Free Survival (PFS) by Investigator Assessment
|
4.0 months
Interval 2.9 to 4.2
|
2.9 months
Interval 2.8 to 3.5
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Participants in the ITT Analysis Set were analyzed.
PFS is defined as the time from the date of randomization to the date of the first objectively documented disease progression (PD), per RECIST v1.1 criteria as determined by BICR, or death regardless of cause, whichever occurs first. PD was defined in outcome measure (OM) #2. KM estimates were used for analysis.
Outcome measures
| Measure |
Sacituzumab Govitecan-hziy (SG)
n=355 Participants
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
n=356 Participants
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR)
|
4.2 months
Interval 3.8 to 4.5
|
3.6 months
Interval 2.9 to 4.2
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Participants in the ITT Analysis Set were analyzed.
ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) as best overall response (BOR) as assessed by investigator assessment. CR was defined as disappearance of all target lesions. PR was defined as ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Percentages were rounded off.
Outcome measures
| Measure |
Sacituzumab Govitecan-hziy (SG)
n=355 Participants
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
n=356 Participants
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Objective Response Rate (ORR) by Investigator Assessment
|
19.7 percentage of participants
Interval 15.7 to 24.2
|
15.7 percentage of participants
Interval 12.1 to 19.9
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Participants in the ITT Analysis Set were analyzed.
ORR was defined as the percentage of participants who achieved a CR or PR as BOR as assessed by BICR. CR and PR are defined in OM#4. Percentages were rounded off.
Outcome measures
| Measure |
Sacituzumab Govitecan-hziy (SG)
n=355 Participants
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
n=356 Participants
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Objective Response Rate (ORR) by BICR
|
22.5 percentage of participants
Interval 18.3 to 27.2
|
13.8 percentage of participants
Interval 10.4 to 17.8
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Participants in the ITT Analysis Set were analyzed.
CBR was defined as the percentage of participants who achieved a BOR of confirmed CR, PR, or stable disease (SD) for ≥ 6 months, per RECIST v1.1, as assessed by investigator assessment. SD is defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started; PD was defined in OM#2; BOR, CR and PR are defined in OM#4. Percentages were rounded off.
Outcome measures
| Measure |
Sacituzumab Govitecan-hziy (SG)
n=355 Participants
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
n=356 Participants
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Clinical Benefit Rate (CBR) by Investigator Assessment
|
31.5 percentage of participants
Interval 26.7 to 36.7
|
21.9 percentage of participants
Interval 17.7 to 26.6
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Participants in the ITT Analysis Set were analyzed.
CBR was defined as the percentage of participants who achieved a BOR of confirmed CR, PR, or SD for ≥ 6 months, per RECIST v1.1, as assessed by BICR. PD was defined in OM#2; BOR, CR and PR are defined in OM#4; SD was defined in OM#6. Percentages were rounded off.
Outcome measures
| Measure |
Sacituzumab Govitecan-hziy (SG)
n=355 Participants
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
n=356 Participants
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Clinical Benefit Rate (CBR) by BICR
|
29.9 percentage of participants
Interval 25.1 to 34.9
|
20.5 percentage of participants
Interval 16.4 to 25.1
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Participants in the ITT Analysis Set with Confirmed CR or PR per Investigator assessment were analyzed.
DOR was defined as the time from the date when the criteria is first met for a CR or PR to the first date that PD is documented per RECIST 1.1 as determined by investigator assessment, or date of death, whichever occurs first. KM estimates were used in analysis. PD was defined in OM#2, CR and PR are defined in OM#4.
Outcome measures
| Measure |
Sacituzumab Govitecan-hziy (SG)
n=70 Participants
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
n=56 Participants
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Duration of Objective Tumor Response (DOR) by Investigator Assessment
|
7.1 months
Interval 5.8 to 9.0
|
5.8 months
Interval 3.7 to 7.0
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Participants in the ITT Analysis Set with Confirmed CR or PR per BICR assessment were analyzed.
DOR was defined as the time from the date when the criteria is first met for a CR or PR to the first date that PD is documented per RECIST 1.1 as determined by BICR, or date of death, whichever occurs first. KM estimates were used in analysis. PD was defined in OM#2, CR and PR are defined in OM#4.
Outcome measures
| Measure |
Sacituzumab Govitecan-hziy (SG)
n=80 Participants
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
n=49 Participants
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Duration of Objective Tumor Response (DOR) by BICR
|
7.2 months
Interval 6.3 to 8.4
|
6.5 months
Interval 5.2 to 8.3
|
SECONDARY outcome
Timeframe: From first dose up to 33.6 monthsPopulation: Participants in the Safety Analysis Set were analyzed. Safety Analysis Set included all participants who were administered with at least 1 dose of SG or Treatment of Physician's Choice.
An adverse event (AE) was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. The SAE was defined as any untoward medical occurrence that at any dose which was fatal (results in death) or life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or an important medical event. TEAEs were defined as an AE that onset in the period from the first dose of study treatment to 30 days after the last dose of study treatment. Percentages were rounded off.
Outcome measures
| Measure |
Sacituzumab Govitecan-hziy (SG)
n=349 Participants
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
n=337 Participants
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAE
|
99.4 percentage of participants
|
95.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAE
|
53.0 percentage of participants
|
32.6 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose up to 33.6 monthsPopulation: Participants in the Safety Analysis Set with at least 1 post-baseline value were analyzed.
A laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time of postbaseline up to and including the date of last study drug dose plus 30 days. Severity grades were defined by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death. Percentages were rounded off.
Outcome measures
| Measure |
Sacituzumab Govitecan-hziy (SG)
n=344 Participants
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
n=315 Participants
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities
|
68.6 percentage of participants
|
36.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0)Population: Participants in the Health-Related Quality of Life (HRQoL) Evaluable Analysis Set were analyzed. HRQoL Evaluable Analysis Set was defined as participants in the ITT Analysis Set who had an evaluable assessment of the EORTC QLQ-C30 at baseline and at least 1 evaluable assessment at postbaseline visits.
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Domain scores were reported for following scales: Physical Functioning, Global Health Status, Pain, and Fatigue Score. Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant). For Symptom scales, a lower score means better quality of life. For Global Health Status and Functional Scales, a higher score signifies better quality of life.
Outcome measures
| Measure |
Sacituzumab Govitecan-hziy (SG)
n=296 Participants
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
n=287 Participants
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score
Functional Scales: Physical Functioning: Baseline
|
74.6 score on scale
Standard Deviation 21.34
|
75.5 score on scale
Standard Deviation 21.81
|
|
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score
Global Health Status / Quality of life (QoL) : Baseline
|
59.6 score on scale
Standard Deviation 21.39
|
62.2 score on scale
Standard Deviation 21.76
|
|
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score
Symptom Scales / Items: Pain : Baseline
|
34.3 score on scale
Standard Deviation 31.83
|
31.7 score on scale
Standard Deviation 28.45
|
|
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score
Symptom Scales / Items: Fatigue : Baseline
|
35.8 score on scale
Standard Deviation 24.34
|
37.4 score on scale
Standard Deviation 25.43
|
SECONDARY outcome
Timeframe: Cycle 5 Day 1; Cycle length = 21 daysPopulation: Participants in the HRQoL Evaluable Analysis Set with available data were analyzed. HRQoL Evaluable Analysis Set was defined as participants in the ITT Analysis Set who had an evaluable assessment of the EORTC QLQ-C30 at baseline and at least 1 evaluable assessment at postbaseline visits.
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Domain scores were reported for following scales: Physical Functioning, Global Health Status, Pain, and Fatigue Score. Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant). For Symptom scales, a lower score means better quality of life. For Global Health Status and Functional Scales, a higher score signifies better quality of life.
Outcome measures
| Measure |
Sacituzumab Govitecan-hziy (SG)
n=162 Participants
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
n=125 Participants
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score
Functional Scales: Physical Functioning: Change from Baseline at Cycle 5 Day 1
|
-7.3 score on scale
Interval -10.1 to -4.5
|
-8.4 score on scale
Interval -11.4 to -5.4
|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score
Global Health Status / QoL : Change from Baseline at Cycle 5 Day 1
|
-1.6 score on scale
Interval -4.6 to 1.4
|
-1.6 score on scale
Interval -4.8 to 1.6
|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score
Symptom Scales / Items: Pain : Change from Baseline at Cycle 5 Day 1
|
-4.2 score on scale
Interval -8.2 to -0.3
|
-1.5 score on scale
Interval -5.7 to 2.7
|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score
Symptom Scales / Items: Fatigue : Change from Baseline at Cycle 5 Day 1
|
5.6 score on scale
Interval 2.0 to 9.1
|
7.6 score on scale
Interval 3.8 to 11.4
|
Adverse Events
Sacituzumab Govitecan-hziy (SG)
Serious events: 185 serious events
Other events: 341 other events
Deaths: 305 deaths
Treatment of Physician's Choice
Serious events: 110 serious events
Other events: 303 other events
Deaths: 310 deaths
Serious adverse events
| Measure |
Sacituzumab Govitecan-hziy (SG)
n=349 participants at risk
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
n=337 participants at risk
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
8/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.89%
3/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.6%
37/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
4.5%
15/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.86%
3/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
1.1%
4/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.6%
16/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
1.8%
6/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Cardiac disorders
Cardiac arrest
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Cardiac disorders
Cardiac failure
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.57%
2/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.57%
2/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Ascites
|
0.57%
2/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Colitis
|
1.4%
5/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Constipation
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.6%
30/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
1.8%
6/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Enteritis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.59%
2/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Ileus
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Intestinal dilatation
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.4%
5/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Nausea
|
0.86%
3/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
1.2%
4/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
1.1%
4/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.89%
3/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
7/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
1.5%
5/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Asthenia
|
1.1%
4/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Chest pain
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Chills
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Death, not otherwise specified
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Fatigue
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
General physical health deterioration
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
1.5%
5/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Hyperthermia
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Malaise
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.59%
2/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Oedema peripheral
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Pain
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.59%
2/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Pyrexia
|
3.2%
11/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
2.1%
7/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.57%
2/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Immune system disorders
Hypersensitivity
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Abscess limb
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Abscess neck
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Bacteraemia
|
0.86%
3/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.59%
2/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Candida infection
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Candida sepsis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Cellulitis
|
0.57%
2/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Clostridial infection
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Covid-19
|
1.1%
4/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.89%
3/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Enterococcal sepsis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Infected urinoma
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Infection
|
0.57%
2/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.89%
3/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Influenza
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Large intestine infection
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Neutropenic sepsis
|
2.9%
10/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.89%
3/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Pneumonia
|
1.1%
4/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
2.1%
7/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Pulmonary sepsis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Pyelitis
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Pyelonephritis
|
0.86%
3/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.59%
2/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Pyelonephritis acute
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Respiratory tract infection
|
0.57%
2/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Sepsis
|
3.4%
12/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
1.2%
4/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Septic shock
|
2.6%
9/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.89%
3/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.57%
2/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.59%
2/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Streptococcal sepsis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.59%
2/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Urinary tract infection
|
4.6%
16/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
3.3%
11/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Urosepsis
|
1.7%
6/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.59%
2/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Vascular device infection
|
0.57%
2/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Injury, poisoning and procedural complications
Fall
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Injury, poisoning and procedural complications
Stoma prolapse
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
Alanine aminotransferase increased
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
Aspartate aminotransferase increased
|
0.57%
2/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
Blood creatinine abnormal
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
Blood creatinine increased
|
1.1%
4/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
Escherichia test positive
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
General physical condition abnormal
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
Neutrophil count decreased
|
2.9%
10/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
1.2%
4/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
Platelet count decreased
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
Sars-cov-2 test positive
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
Troponin I increased
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
White blood cell count decreased
|
1.1%
4/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.86%
3/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
1.5%
5/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.57%
2/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.86%
3/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.89%
3/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Amnesia
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Cerebral infarction
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Encephalopathy
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Headache
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Ischaemic stroke
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Sciatica
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Seizure
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Syncope
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Product Issues
Device occlusion
|
0.57%
2/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
10/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.89%
3/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Renal and urinary disorders
Haematuria
|
1.4%
5/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
1.5%
5/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Renal and urinary disorders
Proteinuria
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Renal and urinary disorders
Renal failure
|
1.1%
4/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.59%
2/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Renal and urinary disorders
Renal impairment
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Renal and urinary disorders
Urinary retention
|
0.57%
2/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.59%
2/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.57%
2/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Reproductive system and breast disorders
Penile haemorrhage
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.89%
3/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.59%
2/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
6/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.57%
2/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Vascular disorders
Deep vein thrombosis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.59%
2/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Vascular disorders
Hypotension
|
0.86%
3/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Vascular disorders
Hypovolaemic shock
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Vascular disorders
May-Thurner syndrome
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Vascular disorders
Peripheral vein thrombosis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.30%
1/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Vascular disorders
Vena cava thrombosis
|
0.29%
1/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
0.00%
0/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
Other adverse events
| Measure |
Sacituzumab Govitecan-hziy (SG)
n=349 participants at risk
Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months).
|
Treatment of Physician's Choice
n=337 participants at risk
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m\^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m\^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
53.3%
186/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
34.4%
116/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.9%
31/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
2.1%
7/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Blood and lymphatic system disorders
Neutropenia
|
26.4%
92/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
6.8%
23/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.3%
22/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
3.0%
10/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.9%
45/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
8.6%
29/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.4%
19/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
2.4%
8/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Constipation
|
29.8%
104/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
19.6%
66/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Diarrhoea
|
54.2%
189/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
18.7%
63/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Nausea
|
45.0%
157/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
17.5%
59/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Stomatitis
|
8.9%
31/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
9.5%
32/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Gastrointestinal disorders
Vomiting
|
22.6%
79/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
5.9%
20/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Asthenia
|
28.4%
99/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
22.0%
74/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Fatigue
|
31.2%
109/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
22.6%
76/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Oedema peripheral
|
8.6%
30/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
8.3%
28/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
General disorders
Pyrexia
|
16.0%
56/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
6.8%
23/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Covid-19
|
12.3%
43/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
8.6%
29/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Infections and infestations
Urinary tract infection
|
11.5%
40/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
9.5%
32/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
Alanine aminotransferase increased
|
9.5%
33/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
3.9%
13/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.2%
18/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
2.7%
9/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
Blood creatinine increased
|
12.0%
42/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
3.3%
11/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
Neutrophil count decreased
|
21.2%
74/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
7.1%
24/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
Platelet count decreased
|
5.2%
18/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
2.7%
9/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
Weight decreased
|
8.3%
29/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
6.8%
23/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Investigations
White blood cell count decreased
|
12.9%
45/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
5.3%
18/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.9%
94/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
17.2%
58/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.3%
22/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
3.9%
13/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.6%
23/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
5.9%
20/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.0%
21/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
3.3%
11/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.5%
40/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
4.7%
16/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.7%
20/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
4.5%
15/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
35/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
3.0%
10/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
22/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
14.2%
48/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
33/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
5.6%
19/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
9/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
9.5%
32/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
13/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
6.2%
21/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Dizziness
|
7.4%
26/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
3.3%
11/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Headache
|
5.4%
19/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
3.6%
12/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Neuropathy peripheral
|
3.4%
12/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
17.5%
59/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.1%
4/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
5.3%
18/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Psychiatric disorders
Insomnia
|
6.0%
21/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
5.3%
18/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Renal and urinary disorders
Haematuria
|
7.2%
25/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
5.6%
19/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
24/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
4.5%
15/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.9%
45/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
9.2%
31/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
39.5%
138/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
33.5%
113/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.2%
25/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
3.3%
11/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.6%
30/349 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
5.3%
18/337 • Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial. Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER