Trial Outcomes & Findings for Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy (NCT NCT04319198)

NCT ID: NCT04319198

Last Updated: 2025-09-30

Results Overview

An adverse event was defined as any untoward medical occurrence in a participant administered a medicinal product that does not necessarily have a causal relationship with this treatment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

First dose date up to 30 days post last dose (Up to 3.9 years)

Results posted on

2025-09-30

Participant Flow

Participants were enrolled at study sites in the United States, Belgium and France.

27 participants were screened. Participants must have been enrolled in other Gilead (previously Immunomedics)-sponsored studies of SG to be eligible to receive continued access to SG in this study.

Participant milestones

Participant milestones
Measure	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) All participants who previously received SG in the parent study (IMMU-132-01) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05) All participants who previously received SG in the parent study (IMMU-132-05) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15) All participants who previously received SG in the parent study (IMMU-132-15) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
Overall Study STARTED	3	10	12
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	3	10	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) All participants who previously received SG in the parent study (IMMU-132-01) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05) All participants who previously received SG in the parent study (IMMU-132-05) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15) All participants who previously received SG in the parent study (IMMU-132-15) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
Overall Study Adverse Events Resolution or Stabilization	3	4	0
Overall Study Death	0	3	3
Overall Study Reason Not Specified	0	2	4
Overall Study Withdrawal of Consent	0	0	5
Overall Study Site Terminated by Sponsor	0	1	0

Baseline Characteristics

Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) n=3 Participants All participants who previously received SG in the parent study (IMMU-132-01) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05) n=10 Participants All participants who previously received SG in the parent study (IMMU-132-05) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15) n=12 Participants All participants who previously received SG in the parent study (IMMU-132-15) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	18 Participants n=4 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Age, Continuous	71 years STANDARD_DEVIATION 5.7 • n=5 Participants	61 years STANDARD_DEVIATION 10.4 • n=7 Participants	49 years STANDARD_DEVIATION 15.5 • n=5 Participants	56 years STANDARD_DEVIATION 14.7 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	21 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	21 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	19 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Belgium	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	3 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants	22 Participants n=4 Participants
Region of Enrollment France	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: First dose date up to 30 days post last dose (Up to 3.9 years)

Population: Participants from All Treated Participants Analysis Set were analyzed.

An adverse event was defined as any untoward medical occurrence in a participant administered a medicinal product that does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) n=3 Participants All participants who previously received SG in the parent study (IMMU-132-01) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05) n=10 Participants All participants who previously received SG in the parent study (IMMU-132-05) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15) n=12 Participants All participants who previously received SG in the parent study (IMMU-132-15) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
Percentage of Participants Experiencing Any Adverse Events	66.7 percentage of participants	100.0 percentage of participants	91.7 percentage of participants

PRIMARY outcome

Timeframe: First dose date up to 30 days post last dose (Up to 3.9 years)

Population: Participants from All Treated Participants Analysis Set were analyzed.

A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, was fatal (resulting in death), was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) n=3 Participants All participants who previously received SG in the parent study (IMMU-132-01) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05) n=10 Participants All participants who previously received SG in the parent study (IMMU-132-05) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15) n=12 Participants All participants who previously received SG in the parent study (IMMU-132-15) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
Percentage of Participants Experiencing Any Serious Adverse Events	0 percentage of participants	40.0 percentage of participants	8.3 percentage of participants

PRIMARY outcome

Timeframe: First dose date up to 30 days post last dose (Up to 3.9 years)

Population: Participants from All Treated Participants Analysis Set with at least 1 grade change postbaseline were analyzed.

The percentage of participants experiencing any clinically significant laboratory abnormality was summarized.

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) n=3 Participants All participants who previously received SG in the parent study (IMMU-132-01) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05) n=9 Participants All participants who previously received SG in the parent study (IMMU-132-05) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15) n=11 Participants All participants who previously received SG in the parent study (IMMU-132-15) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities Any Grade 1 or Higher Laboratory Abnormalities	100.0 percentage of participants	88.9 percentage of participants	81.8 percentage of participants
Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities Grade 3 or 4 Laboratory Abnormalities	33.3 percentage of participants	44.4 percentage of participants	72.7 percentage of participants

Adverse Events

Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05)

Serious events: 4 serious events

Other events: 10 other events

Deaths: 3 deaths

Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15)

Serious events: 1 serious events

Other events: 11 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) n=3 participants at risk All participants who previously received SG in the parent study (IMMU-132-01) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05) n=10 participants at risk All participants who previously received SG in the parent study (IMMU-132-05) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15) n=12 participants at risk All participants who previously received SG in the parent study (IMMU-132-15) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	0.00% 0/10 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	8.3% 1/12 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.
Gastrointestinal disorders Colitis	0.00% 0/3 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	10.0% 1/10 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	0.00% 0/12 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	0.00% 0/10 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	8.3% 1/12 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.
General disorders Chest pain	0.00% 0/3 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	10.0% 1/10 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	0.00% 0/12 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.
Infections and infestations Covid-19	0.00% 0/3 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	10.0% 1/10 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	0.00% 0/12 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	10.0% 1/10 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	0.00% 0/12 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	0.00% 0/10 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	8.3% 1/12 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.
Vascular disorders Lymphoedema	0.00% 0/3 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	10.0% 1/10 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.	0.00% 0/12 • Up to 3.9 years All-Cause Mortality included all deaths occurred during study due to any cause among participants from All Treated Participants Analysis Set. Adverse Events included any serious or other (not including serious) AEs among All Treated Participants Analysis Set defined as all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.

Other adverse events

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