Trial Outcomes & Findings for QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed (NCT NCT03387111)
NCT ID: NCT03387111
Last Updated: 2024-08-05
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
4 participants
Primary outcome timeframe
30 days after last dose, up to 15.5 months
Results posted on
2024-08-05
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 Squamous Cell Carcinoma (SCC) Vaccine
Combination of agents were administered in this study: Aldoxorubicin HCl, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, necitumumab, SBRT.
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|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
NANT Squamous Cell Carcinoma (SCC) Vaccine
Combination of agents were administered in this study: Aldoxorubicin HCl, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, necitumumab, SBRT.
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|---|---|
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Overall Study
Progressive Disease
|
3
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed
Baseline characteristics by cohort
| Measure |
NANT Squamous Cell Carcinoma (SCC) Vaccine
n=4 Participants
Combination of agents will be administered in this study: Aldoxorubicin HCl, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, necitumumab, SBRT.
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|---|---|
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Age, Continuous
|
63.5 years
STANDARD_DEVIATION 10.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
1 Participants
n=5 Participants
|
|
Subjects with SCC who have progressed
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days after last dose, up to 15.5 monthsGraded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Outcome measures
| Measure |
NANT Squamous Cell Carcinoma (SCC) Vaccine
n=4 Participants
Combination of agents will be administered in this study: Aldoxorubicin HCl, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, necitumumab, SBRT.
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|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
|
4 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 11 months.Population: 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 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 Squamous Cell Carcinoma (SCC) Vaccine
n=4 Participants
Combination of agents will be administered in this study: Aldoxorubicin HCl, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, necitumumab, 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 11 months.Population: 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 Squamous Cell Carcinoma (SCC) Vaccine
n=4 Participants
Combination of agents will be administered in this study: Aldoxorubicin HCl, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, necitumumab, SBRT.
|
|---|---|
|
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 11 months.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions 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 Squamous Cell Carcinoma (SCC) Vaccine
n=4 Participants
Combination of agents will be administered in this study: Aldoxorubicin HCl, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, necitumumab, SBRT.
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|---|---|
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Progression Free Survival by RECIST Version 1.1.
|
5.3 Months
Interval 0.8 to
NA = 95% Confidence Interval upper limit was not calculable due to an 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, up to 11 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 Squamous Cell Carcinoma (SCC) Vaccine
n=4 Participants
Combination of agents will be administered in this study: Aldoxorubicin HCl, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, necitumumab, SBRT.
|
|---|---|
|
Progression Free Survival by irRC
|
5.7 Months
Interval 4.9 to
NA = 95% Confidence Interval upper limit was not calculable due to an 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 Squamous Cell Carcinoma (SCC) Vaccine
n=4 Participants
Combination of agents will be administered in this study: Aldoxorubicin HCl, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, necitumumab, SBRT.
|
|---|---|
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Overall Survival
|
15.1 Months
Interval 6.4 to
NA = 95% Confidence Interval upper limit was not calculable due to an 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, up to 11 months.Population: There were no participants with confirmed CR or PR. Therefore, no participants were included in the DOR analysis.
DOR was defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occurred first. Responding subjects completed study follow-up or initiated a new anticancer therapy prior to documented PD was 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
| Measure |
NANT Squamous Cell Carcinoma (SCC) Vaccine
n=4 Participants
Combination of agents will be administered in this study: Aldoxorubicin HCl, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, necitumumab, SBRT.
|
|---|---|
|
Duration of Response (DOR) by RECIST Version 1.1 and irRC
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 11 monthsDisease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months
Outcome measures
| Measure |
NANT Squamous Cell Carcinoma (SCC) Vaccine
n=4 Participants
Combination of agents will be administered in this study: Aldoxorubicin HCl, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, necitumumab, SBRT.
|
|---|---|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1
Confirmed Complete 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
Confirmed 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
Unconfirmed Complete 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
Unconfirmed Partial Response
|
1 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1
Stable Disease
|
1 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1
Progressive Disease
|
1 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1
Imaging Not Available to Evaluate
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 15.5 monthsPopulation: There were 2 QOLs planned on study, FACT-L/FACT-H\&N. No participants took the FACT-L. There is no data to summarize. The FACT H\&N was performed during the study for 1 participant. The only other participant who took the FACT-H\&N performed this QOL at screening only. There is no QOL data to summarize. According to the approved SAP, FACT-H\&N/FACT-L scores at baseline and post-baseline time points were to be presented in a data listing. The results of the PRO were not planned to be summarized.
QoL was conducted via PROs using the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H\&N) or Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire. The FACT-H\&N and FACT-L compilation of general questions divided into five QoL subscales: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Additional Concerns. It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much'. Each subscale consists of 6-12 questions to answer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 11 monthsDisease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months
Outcome measures
| Measure |
NANT Squamous Cell Carcinoma (SCC) Vaccine
n=4 Participants
Combination of agents will be administered in this study: Aldoxorubicin HCl, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, necitumumab, SBRT.
|
|---|---|
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Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
Confirmed irCR
|
0 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
Confirmed irPR
|
0 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
Unconfirmed irCR
|
0 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
Unconfirmed irPR
|
1 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
irSD
|
2 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
Unconfirmed irPD
|
0 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
Confirmed irPD
|
0 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
Imaging not available to evaluate
|
1 Participants
|
Adverse Events
NANT Squamous Cell Carcinoma (SCC) Vaccine
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
NANT Squamous Cell Carcinoma (SCC) Vaccine
n=4 participants at risk
Combination of agents will be administered in this study: Aldoxorubicin HCl, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, necitumumab, SBRT.
|
|---|---|
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Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Infections and infestations
Abscess
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Infections and infestations
Wound infection
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Vascular disorders
Haemorrhage
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
Other adverse events
| Measure |
NANT Squamous Cell Carcinoma (SCC) Vaccine
n=4 participants at risk
Combination of agents will be administered in this study: Aldoxorubicin HCl, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, necitumumab, SBRT.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
75.0%
3/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Gastrointestinal disorders
Anal fistula
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Gastrointestinal disorders
Mouth ulceration
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
General disorders
Fatigue
|
100.0%
4/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
General disorders
Pyrexia
|
100.0%
4/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
General disorders
Chills
|
75.0%
3/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
General disorders
Injection site reaction
|
75.0%
3/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
General disorders
Face oedema
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
General disorders
Mucosal inflammation
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
General disorders
Asthenia
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
General disorders
Catheter site pain
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
General disorders
Extravasation
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Investigations
Weight decreased
|
75.0%
3/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Investigations
Blood pressure increased
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Investigations
Blood testosterone decreased
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Investigations
Breath sounds abnormal
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Infections and infestations
Conjunctivitis
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Infections and infestations
Abscess
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Infections and infestations
Catheter site cellulitis
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Infections and infestations
Cellulitis
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Infections and infestations
Wound infection
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
75.0%
3/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Metabolism and nutrition disorders
Malnutrition
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Nervous system disorders
Hypoaesthesia
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Nervous system disorders
Paraesthesia
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Renal and urinary disorders
Proteinuria
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Renal and urinary disorders
Urinary hesitation
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Vascular disorders
Hypotension
|
50.0%
2/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Vascular disorders
Deep vein thrombosis
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Vascular disorders
Haemorrhage
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Vascular disorders
Jugular vein thrombosis
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Cardiac disorders
Atrial fibrillation
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Eye disorders
Dry eye
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Immune system disorders
Hypersensitivity
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
|
|
Injury, poisoning and procedural complications
Anxiety
|
25.0%
1/4 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. 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.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place