Trial Outcomes & Findings for QUILT-3.080: NANT Pancreatic Cancer Vaccine (NCT NCT03586869)
NCT ID: NCT03586869
Last Updated: 2024-08-27
Results Overview
Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Up to 230 days
Results posted on
2024-08-27
Participant Flow
Only the Phase 1b portion of the study enrolled participants. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study. Eligible participants could have gone through both induction and maintenance treatment on study.
Participant milestones
| Measure |
NANT Pancreatic Cancer Vaccine
A combination of agents were administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).
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|---|---|
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Overall Study
STARTED
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3
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Overall Study
COMPLETED
|
0
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
NANT Pancreatic Cancer Vaccine
A combination of agents were administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).
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|---|---|
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Overall Study
Progressive Disease
|
3
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Baseline Characteristics
QUILT-3.080: NANT Pancreatic Cancer Vaccine
Baseline characteristics by cohort
| Measure |
NANT Pancreatic Cancer Vaccine
n=3 Participants
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).
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|---|---|
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Age, Continuous
|
67.3 years
STANDARD_DEVIATION 5.77 • n=5 Participants
|
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
subjects with pancreatic cancer who have progressed on or after standard-of-care therapy
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3 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 230 daysGraded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=3 Participants
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).
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|---|---|
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Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Treatment-Emergent Adverse Events
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Treatment-Emergent Serious Adverse Events
|
2 Participants
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression, up to 6.8 monthsTumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with RECIST Version 1.1. An objective response is defined as a confirmed complete or partial overall response with confirmation occurring at least 4 weeks after the initial response is observed.
Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=3 Participants
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).
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|---|---|
|
Objective Response Rate by RECIST Version 1.1
|
0 Participants
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 6.8 monthsPopulation: No participants had either confirmed partial response or complete response on study. Therefore, objective response rate is 0.
Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with immune-related response criteria (irRC). An objective response is defined as a confirmed complete or partial overall response with confirmation occurring at least 4 weeks after the initial response is observed.
Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=3 Participants
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).
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|---|---|
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Objective Response Rate by irRC
|
0 Participants
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first, up to 6.8 months.PFS was evaluated using Kaplan-Meier methods. PFS was defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Subjects completing study follow-up or initiating a new anticancer therapy prior to documented PD was censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating the new therapy.
Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=3 Participants
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).
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|---|---|
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Progression Free Survival by RECIST Version 1.1.
|
1.7 Months
Interval 0.5 to
NA = insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first.PFS was evaluated using Kaplan-Meier methods. PFS was defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Subjects completing study follow-up or initiating a new anticancer therapy prior to documented PD was censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating the new therapy.
Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=3 Participants
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).
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|---|---|
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Progression Free Survival by irRC
|
1.7 Months
Interval 0.5 to
NA = insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Participants were assessed from screening to death.OS was evaluated using Kaplan-Meier methods. OS was defined as the time from the date of first treatment to the date of death (any cause). Participants who were alive at the end of follow-up were censored in the OS analysis at the last known date alive.
Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=3 Participants
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).
|
|---|---|
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Overall Survival
|
4.6 Months
Interval 2.5 to
NA = insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 6.8 monthsPopulation: There were no participants with confirmed CR or PR. Therefore, no participants were included in the DOR analysis.
DOR was be defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occurs first. Responding subjects completed study follow-up or initiating a new anticancer therapy prior to documented PD were censored in the DOR analysis at the last known date the subject was progression free prior completing follow-up or initiating the new therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 6.8 monthsDisease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months.
Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=3 Participants
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).
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|---|---|
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Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1 and irRC
Complete Response
|
0 Participants
|
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Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1 and irRC
Partial Response
|
0 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1 and irRC
Stable Disease
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days after last dose, up 12.7 monthsPopulation: The questionnaire was not completed for every patient at every visit.
PROs were assessed using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep is compilation of general questions divided into five QOL subscales: Physical Well-Being - Scores ranging from 0-28 Social/Family Well-Being - Scores ranging from 0-28 Emotional Well-Being - Scores ranging from 0-24 Functional Well-Being - Scores ranging from 0-28 Additional Concerns - Scores ranging from 0-72 It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much' The higher scales and subscales indicate better quality of life. Negatively worded items were reverse scored. If the missing for each subscale was less than 50%, the prorating scores were computed for the subscale.
Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=3 Participants
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).
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|---|---|
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Quality of Life by Patient Reported Outcomes (PRO)
Functional Well-Being - (I) C3D1
|
18.0 score on a scale
Interval 15.0 to 21.0
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Quality of Life by Patient Reported Outcomes (PRO)
Physical Well-Being - Baseline
|
13.3 score on a scale
Interval 11.7 to 15.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Physical Well-Being - (I) C3D1
|
16.5 score on a scale
Interval 14.0 to 19.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Physical Well-Being - (I) C5D1
|
9.0 score on a scale
Interval 9.0 to 9.0
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|
Quality of Life by Patient Reported Outcomes (PRO)
Physical Well-Being - (I) C7D1
|
11.0 score on a scale
Interval 11.0 to 11.0
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Quality of Life by Patient Reported Outcomes (PRO)
Physical Well-Being - (I) C9D1
|
3.0 score on a scale
Interval 3.0 to 3.0
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|
Quality of Life by Patient Reported Outcomes (PRO)
Physical Well-Being - (M) C1D1
|
12.0 score on a scale
Interval 12.0 to 12.0
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|
Quality of Life by Patient Reported Outcomes (PRO)
Physical Well-Being - End of Treatment
|
22.0 score on a scale
Interval 22.0 to 22.0
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|
Quality of Life by Patient Reported Outcomes (PRO)
Social/Family Well-Being - Baseline
|
25.5 score on a scale
Interval 23.0 to 28.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Social/Family Well-Being- (I) C3D1
|
26.0 score on a scale
Interval 24.0 to 28.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Social/Family Well-Being- (I) C5D1
|
20.0 score on a scale
Interval 20.0 to 20.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Social/Family Well-Being - (I) C7D1
|
25.0 score on a scale
Interval 25.0 to 25.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Social/Family Well-Being - (I) C9D1
|
23.0 score on a scale
Interval 23.0 to 23.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Social/Family Well-Being - (M) C1D1
|
18.0 score on a scale
Interval 18.0 to 18.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Social/Family Well-Being - End of Treatment
|
28.0 score on a scale
Interval 28.0 to 28.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Emotional Well-Being - Baseline
|
19.0 score on a scale
Interval 16.0 to 22.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Emotional Well-Being - (I) C3D1
|
20.5 score on a scale
Interval 19.0 to 22.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Emotional Well-Being - (I) C5D1
|
18.0 score on a scale
Interval 18.0 to 18.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Emotional Well-Being - (I) C7D1
|
14.0 score on a scale
Interval 14.0 to 14.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Emotional Well-Being - (I) C9D1
|
13.0 score on a scale
Interval 13.0 to 13.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Emotional Well-Being - (M) C1D1
|
8.0 score on a scale
Interval 8.0 to 8.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Emotional Well-Being - End of Treatment
|
21.0 score on a scale
Interval 21.0 to 21.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Functional Well-Being - Baseline
|
15.0 score on a scale
Interval 8.0 to 22.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Functional Well-Being - (I) C5D1
|
17.0 score on a scale
Interval 17.0 to 17.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Functional Well-Being - (I) C7D1
|
12.0 score on a scale
Interval 12.0 to 12.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Functional Well-Being - (I) C9D1
|
9.0 score on a scale
Interval 9.0 to 9.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Functional Well-Being - (M) C1D1
|
10.0 score on a scale
Interval 10.0 to 10.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Functional Well-Being - End of Treatment
|
20.0 score on a scale
Interval 20.0 to 20.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Additional Concerns - Baseline
|
42.4 score on a scale
Interval 36.0 to 49.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Additional Concerns - (I) C3D1
|
41.3 score on a scale
Interval 36.0 to 46.6
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Additional Concerns - (I) C5D1
|
42.0 score on a scale
Interval 42.0 to 42.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Additional Concerns - (I) C7D1
|
32.0 score on a scale
Interval 32.0 to 32.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Additional Concerns - (I) C9D1
|
33.0 score on a scale
Interval 33.0 to 33.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Additional Concerns - (M) C1D1
|
40.0 score on a scale
Interval 40.0 to 40.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Additional Concerns - End of Treatment
|
47.0 score on a scale
Interval 47.0 to 47.0
|
Adverse Events
NANT Pancreatic Cancer Vaccine
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
NANT Pancreatic Cancer Vaccine
n=3 participants at risk
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).
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|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
General disorders
Disease progression
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Infections and infestations
Clostridium difficile infection
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
Other adverse events
| Measure |
NANT Pancreatic Cancer Vaccine
n=3 participants at risk
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).
|
|---|---|
|
General disorders
Fatigue
|
100.0%
3/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
General disorders
Disease progression
|
66.7%
2/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
General disorders
Pyrexia
|
66.7%
2/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
General disorders
Catheter site haemorrhage
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
General disorders
Chills
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
General disorders
Gait disturbance
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
General disorders
Generalised oedema
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
General disorders
Injection site erythema
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
General disorders
Injection site reaction
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
General disorders
Mucosal dryness
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Gastrointestinal disorders
Mouth ulceration
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Gastrointestinal disorders
Obstruction gastric
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Infections and infestations
Clostridium difficile infection
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Injury, poisoning and procedural complications
Nail injury
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Vascular disorders
Deep vein thrombosis
|
66.7%
2/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Investigations
Electrocardiogram T wave inversion
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Investigations
Hyponatraemia
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
33.3%
1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place