Trial Outcomes & Findings for Safety and Efficacy Study of SL-701, a Glioma-Associated Antigen Vaccine To Treat Recurrent Glioblastoma Multiforme (NCT NCT02078648)
NCT ID: NCT02078648
Last Updated: 2025-02-03
Results Overview
RLT included any events that occurred anytime through the first 12 doses of study treatment that were considered possibly, probably, or definitely related to investigational therapy and ranged from Grade ≥3 bronchospasm or Grade 2 bronchospasm that did not resolve within 24 hours despite appropriate medical treatment to cerebral edema associated with severe clinical manifestations (Grade 4) that were considered related to study therapy by the investigator.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
74 participants
Primary outcome timeframe
Approximately 24 weeks
Results posted on
2025-02-03
Participant Flow
Participant milestones
| Measure |
SL-701 + GM-CSF + Imiquimod
Participants received SL-701 with the vaccine adjuvants granulocyte-macrophage colony-stimulating factor (GM-CSF) injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion subcutaneous (SC) injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 hours (h) after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 micrograms (μg) close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
SL-701 emulsion and the adjuvant polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose (poly-ICLC) were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an intramuscular (IM) injection in the same extremity (within 3 centimeters \[cm\] whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered intravenously (IV) at a dose of 10 milligrams/kilogram (mg/kg). Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
28
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
46
|
28
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
46
|
28
|
Reasons for withdrawal
| Measure |
SL-701 + GM-CSF + Imiquimod
Participants received SL-701 with the vaccine adjuvants granulocyte-macrophage colony-stimulating factor (GM-CSF) injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion subcutaneous (SC) injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 hours (h) after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 micrograms (μg) close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
SL-701 emulsion and the adjuvant polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose (poly-ICLC) were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an intramuscular (IM) injection in the same extremity (within 3 centimeters \[cm\] whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered intravenously (IV) at a dose of 10 milligrams/kilogram (mg/kg). Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|---|---|---|
|
Overall Study
Unequivocal Evidence of Disease Progression
|
36
|
13
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
General Deterioration in Performance Status Without Radiographic Evidence of Disease Progression
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Investigator Decision
|
5
|
7
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Undefined
|
0
|
1
|
Baseline Characteristics
Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701 and with the last non-missing assessment taken prior to administration of the first SL-701 injection.
Baseline characteristics by cohort
| Measure |
SL-701 + GM-CSF + Imiquimod
n=46 Participants
Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
n=28 Participants
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 years
n=46 Participants
|
60.0 years
n=28 Participants
|
55.6 years
n=74 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=46 Participants
|
10 Participants
n=28 Participants
|
26 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=46 Participants
|
18 Participants
n=28 Participants
|
48 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=46 Participants
|
0 Participants
n=28 Participants
|
2 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=46 Participants
|
25 Participants
n=28 Participants
|
64 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=46 Participants
|
3 Participants
n=28 Participants
|
8 Participants
n=74 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=46 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=46 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=46 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=46 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=74 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=46 Participants
|
25 Participants
n=28 Participants
|
65 Participants
n=74 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=46 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=46 Participants
|
3 Participants
n=28 Participants
|
7 Participants
n=74 Participants
|
|
Body Mass Index
|
28.3 kilogram/meter squared
STANDARD_DEVIATION 6.0 • n=41 Participants • Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701 and with the last non-missing assessment taken prior to administration of the first SL-701 injection.
|
29.4 kilogram/meter squared
STANDARD_DEVIATION 6.2 • n=24 Participants • Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701 and with the last non-missing assessment taken prior to administration of the first SL-701 injection.
|
28.7 kilogram/meter squared
STANDARD_DEVIATION 6.0 • n=65 Participants • Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701 and with the last non-missing assessment taken prior to administration of the first SL-701 injection.
|
PRIMARY outcome
Timeframe: Approximately 24 weeksPopulation: Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
RLT included any events that occurred anytime through the first 12 doses of study treatment that were considered possibly, probably, or definitely related to investigational therapy and ranged from Grade ≥3 bronchospasm or Grade 2 bronchospasm that did not resolve within 24 hours despite appropriate medical treatment to cerebral edema associated with severe clinical manifestations (Grade 4) that were considered related to study therapy by the investigator.
Outcome measures
| Measure |
SL-701 + GM-CSF + Imiquimod
n=46 Participants
Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
n=28 Participants
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|---|---|---|
|
Number of Participants Experiencing Regimen-limiting Toxicity (RLT)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Month 12Population: Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
A safety review occurred following each sudden or unexpected death that was not considered by the investigator to be a disease-related mortality and was considered to be related to SL-701.
Outcome measures
| Measure |
SL-701 + GM-CSF + Imiquimod
n=46 Participants
Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
n=28 Participants
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|---|---|---|
|
Number of Participants Experiencing Sudden or Unexpected Death Related to SL-701 or SL-701 in Combination With Bevacizumab
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
OS-12 was defined as the number of participants surviving at 12 months after the first injection of SL-701 and was calculated using the Clopper-Pearson Method.
Outcome measures
| Measure |
SL-701 + GM-CSF + Imiquimod
n=46 Participants
Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
n=28 Participants
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|---|---|---|
|
Overall Survival at 12 Months (OS-12)
|
20 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
ORR was the percentage of participants who had at least 1 overall tumor response of complete response (CR) or partial response (PR) documented on 2 consecutive magnetic resonance images (MRIs) ≥4 weeks apart by modified response assessment in neuro-oncology (RANO) criteria.
Outcome measures
| Measure |
SL-701 + GM-CSF + Imiquimod
n=46 Participants
Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
n=28 Participants
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
2.2 percentage of participants
Interval 0.1 to 9.9
|
14.3 percentage of participants
Interval 5.0 to 29.8
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
DCR was the percentage of participants whose best response was either CR, PR, or stable disease (SD) documented on 2 consecutive MRIs ≥4 weeks apart by modified RANO criteria.
Outcome measures
| Measure |
SL-701 + GM-CSF + Imiquimod
n=46 Participants
Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
n=28 Participants
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
21.7 percentage of participants
Interval 10.9 to 36.4
|
53.6 percentage of participants
Interval 33.9 to 72.5
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
DoR was defined as the time from the date measurement criteria were first met for objective response (either CR or PR) until the first date that the criteria for progressive disease (PD) was met, or death due to any cause, whichever occurred first, by modified RANO. If a participant did not progress or die after a response of CR or PR, then the participant's DoR was censored at the date of the participant's last tumor assessment. Only participants who attained a confirmed response of either CR or PR were included in the estimation of DoR (calculated using the Kaplan-Meier method).
Outcome measures
| Measure |
SL-701 + GM-CSF + Imiquimod
n=1 Participants
Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
n=4 Participants
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|---|---|---|
|
Duration of Response (DoR)
|
NA month
Values were non-estimable (insufficient number of participants with events).
|
8.8 month
Values were non-estimable (high censoring rates).
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
DDC was defined as the time from the date measurement criteria were first met for objective response (either CR, PR, or SD) until the first date that the criteria for PD were met, or death due to any cause, whichever occurs first, by modified RANO. If a participant did not progress or die after a response of CR, PR or SD, then the participant's DDC was censored at the date of the participant's last tumor assessment. Only participants who attained a confirmed response of either CR, PR or SD were included in the estimation of DDC.
Outcome measures
| Measure |
SL-701 + GM-CSF + Imiquimod
n=10 Participants
Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
n=15 Participants
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|---|---|---|
|
Duration of Disease Control (DDC)
|
9.2 month
Interval 3.8 to
Values were non-estimable (insufficient number of participants with events).
|
8.8 month
Interval 3.7 to
Values were non-estimable (insufficient number of participants with events).
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
PFS-6 was defined as the time from the date of the first injection of SL-701 to the date of disease progression or death from any cause, whichever occurred first, by modified RANO. Participants who had not progressed or died at the time of the analysis were censored at the date of their latest tumor assessment or survival assessment.
Outcome measures
| Measure |
SL-701 + GM-CSF + Imiquimod
n=46 Participants
Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
n=28 Participants
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|---|---|---|
|
Progression-free Survival at 6 Months (PFS-6)
|
1.9 month
Interval 1.8 to 2.7
|
5.6 month
Interval 3.3 to
Values were non-estimable (insufficient number of participants with events).
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
PFS-12 was defined as the time from the date of the first injection of SL-701 to the date of disease progression or death from any cause, whichever occurred first, by modified RANO. Participants who had not progressed or died at the time of the analysis were censored at the date of their latest tumor assessment.
Outcome measures
| Measure |
SL-701 + GM-CSF + Imiquimod
n=46 Participants
Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
n=28 Participants
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|---|---|---|
|
Progression-free Survival at 12 Months (PFS-12)
|
1.9 month
Interval 1.8 to 2.7
|
5.6 month
Interval 3.6 to 10.0
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
PFS was defined as the time from the date of the first injection of SL-701 to the date of disease progression or death from any cause, whichever occurred first, by modified RANO. Participants who had not progressed or died at the time of the analysis were censored at the date of their latest tumor assessment.
Outcome measures
| Measure |
SL-701 + GM-CSF + Imiquimod
n=46 Participants
Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
n=28 Participants
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
1.9 month
Interval 1.8 to 2.7
|
5.6 month
Interval 3.6 to 10.0
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
OS was the time from the date of the first SL-701 injection to the date of death from any cause. If a participant did not die during the study, the participant's overall survival time was censored at the date at which the participant was last known to be alive.
Outcome measures
| Measure |
SL-701 + GM-CSF + Imiquimod
n=46 Participants
Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
n=28 Participants
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|---|---|---|
|
Overall Survival (OS)
|
10.9 month
Interval 8.2 to 12.0
|
11.7 month
Interval 7.1 to
Values were non-estimable (insufficient number of participants with events).
|
Adverse Events
SL-701 + GM-CSF + Imiquimod
Serious events: 14 serious events
Other events: 42 other events
Deaths: 38 deaths
SL-701 + Poly-ICLC + Bevacizumab
Serious events: 9 serious events
Other events: 28 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
SL-701 + GM-CSF + Imiquimod
n=46 participants at risk
Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
n=28 participants at risk
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|---|---|---|
|
Eye disorders
Vision blurred
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Asthenia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Fatigue
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Oedema peripheral
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Performance status decreased
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Pyrexia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Wound infection
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritumoural oedema
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Seizure
|
8.7%
4/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Hemiparesis
|
8.7%
4/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Encephalopathy
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Headache
|
6.5%
3/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Haemorrhage intracranial
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Cerebral haemorrhage
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Dysarthria
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Focal dyscognitive seizures
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Somnolence
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Mental status changes
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Mania
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Psychotic disorder
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
Other adverse events
| Measure |
SL-701 + GM-CSF + Imiquimod
n=46 participants at risk
Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream.
A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.
In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later.
|
SL-701 + Poly-ICLC + Bevacizumab
n=28 participants at risk
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|---|---|---|
|
Eye disorders
Eye pain
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Eye disorders
Eye swelling
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Eye disorders
Mydriasis
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Flatulence
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.7%
4/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
10.7%
3/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.5%
3/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Nausea
|
19.6%
9/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
21.4%
6/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Vomiting
|
17.4%
8/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
14.3%
4/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Constipation
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
17.9%
5/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
10.7%
3/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
3/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Fatigue
|
23.9%
11/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
60.7%
17/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Injection site reaction
|
15.2%
7/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
28.6%
8/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Gait disturbance
|
10.9%
5/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
25.0%
7/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Injection site erythema
|
15.2%
7/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
14.3%
4/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Injection site pain
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
25.0%
7/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Influenza like illness
|
6.5%
3/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
14.3%
4/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Injection site induration
|
15.2%
7/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Chills
|
8.7%
4/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Injection site swelling
|
8.7%
4/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Injection site rash
|
6.5%
3/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Asthenia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Pyrexia
|
6.5%
3/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Candida infection
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
10.7%
3/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Sinusitis
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Fall
|
10.9%
5/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
32.1%
9/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.5%
3/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
10.7%
3/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
10.7%
3/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
10.7%
3/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
4/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
21.4%
6/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.7%
4/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
17.9%
5/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
21.4%
6/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
21.4%
6/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
3/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Headache
|
21.7%
10/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
39.3%
11/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Aphasia
|
15.2%
7/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
21.4%
6/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Hemiparesis
|
17.4%
8/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
14.3%
4/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Seizure
|
10.9%
5/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Dizziness
|
6.5%
3/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
10.7%
3/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Cognitive disorder
|
8.7%
4/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Paraesthesia
|
6.5%
3/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Memory impairment
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Somnolence
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Amnesia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Tremor
|
6.5%
3/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Confusional state
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
17.9%
5/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Insomnia
|
10.9%
5/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Anxiety
|
6.5%
3/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
10.7%
3/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Depression
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
10.7%
3/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Abulia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Renal and urinary disorders
Proteinuria
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
21.4%
6/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Renal and urinary disorders
Haematuria
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
10.7%
3/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
10.7%
3/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
14.3%
4/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
10.7%
3/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.5%
3/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
10.7%
3/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
14.3%
4/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
6.5%
3/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
7.1%
2/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
10.7%
3/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Vascular disorders
Hypertension
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
32.1%
9/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Cardiac disorders
Sinus tachycardia
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Eye disorders
Vision blurred
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Eye disorders
Blepharospasm
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Eye disorders
Conjunctival irritation
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Eye disorders
Diplopia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Eye disorders
Eye irritation
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Lip swelling
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Gastrointestinal disorders
Loose tooth
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Malaise
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Chest pain
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Generalised oedema
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Injection site bruising
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Injection site discomfort
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Nodule
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Oedema
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Cellulitis
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Influenza
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Injection site cellulitis
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Injection site infection
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Respiratory tract infection
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Skin infection
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Infections and infestations
Wound infection
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Laceration
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Wound
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Investigations
Blood pressure increased
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Investigations
Drug level decreased
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Investigations
International normalised ratio increased
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Metabolism and nutrition disorders
Overweight
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritumoural oedema
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Balance disorder
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Ataxia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Disturbance in attention
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Dysarthria
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Facial paresis
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Hypoaesthesia
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Apraxia
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Clumsiness
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Dysaesthesia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Dysgeusia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Facial paralysis
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Fine motor delay
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Haemorrhage intracranial
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Muscular weakness
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Neurological symptom
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Nervous system disorders
Visual field defect
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Depressed mood
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Disorientation
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Frustration tolerance decreased
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Hyposomnia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Mental status changes
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Mood altered
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Restlessness
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Psychiatric disorders
Suicidal ideation
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Renal and urinary disorders
Pollakiuria
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Renal and urinary disorders
Urinary retention
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/30 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
5.6%
1/18 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Respiratory, thoracic and mediastinal disorders
Dysaesthesia pharynx
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Vascular disorders
Flushing
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Vascular disorders
Deep vein thrombosis
|
2.2%
1/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
0.00%
0/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Vascular disorders
Hot flush
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Induration
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Injection site pruritus
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
|
General disorders
Oedema peripheral
|
4.3%
2/46 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
3.6%
1/28 • All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
|
Additional Information
Clinical Development & Medical Affairs - Solid Tumors
Stemline Therapeutics, Inc.
Phone: 1-973-775-2845
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place