Trial Outcomes & Findings for Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1 (NCT NCT02650986)
NCT ID: NCT02650986
Last Updated: 2025-06-17
Results Overview
Will be assessed using Common Toxicity Criteria. Patients will be monitored by medical histories, physical examinations, ophthalmologic exams, and blood studies to detect potential toxicities from the treatment. the number of patients experiencing a DLT are reported.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Up to 30 days
Results posted on
2025-06-17
Participant Flow
Participant milestones
| Measure |
Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^7
|
Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^8
|
Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^9
|
Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Decitabine: Given IV at 20 mg/m\^2 x 3 days
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^9
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1
Baseline characteristics by cohort
| Measure |
Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)
n=3 Participants
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^7
|
Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)
n=3 Participants
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^8
|
Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
n=3 Participants
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^9
|
Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
n=6 Participants
Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^9
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Continuous
|
62.2 Year
STANDARD_DEVIATION 8.3 • n=5 Participants
|
61.4 Year
STANDARD_DEVIATION 2.0 • n=7 Participants
|
60.1 Year
STANDARD_DEVIATION 2.7 • n=5 Participants
|
43.8 Year
STANDARD_DEVIATION 18.4 • n=4 Participants
|
54.3 Year
STANDARD_DEVIATION 14.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysWill be assessed using Common Toxicity Criteria. Patients will be monitored by medical histories, physical examinations, ophthalmologic exams, and blood studies to detect potential toxicities from the treatment. the number of patients experiencing a DLT are reported.
Outcome measures
| Measure |
Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)
n=3 Participants
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV at 1 x 10\^7
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
|
Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)
n=3 Participants
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV at 1 x 10\^8
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
|
Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
n=3 Participants
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV at 1 x 10\^9
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
|
Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
n=6 Participants
Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV at 1 x 10\^9
Decitabine: Given IV at 20 mg/m\^2 x 3 days
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
|
|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 monthUnfeasibility will be defined as 3 or more preparations not meeting the lot release criteria in each cohort. Sufficient numbers of circulating, lot released confirmed T cells will be measured prior to administration. The count of patients not meeting the preparation criteria are reported.
Outcome measures
| Measure |
Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)
n=3 Participants
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV at 1 x 10\^7
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
|
Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)
n=3 Participants
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV at 1 x 10\^8
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
|
Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
n=3 Participants
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV at 1 x 10\^9
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
|
Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
n=6 Participants
Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV at 1 x 10\^9
Decitabine: Given IV at 20 mg/m\^2 x 3 days
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
|
|---|---|---|---|---|
|
Number of Participants With Feasibility Concerns in Manufacturing of NY-ESO-1/ dnTGFbetaRII Engineered Cells
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 15 yearsTCR and vector presence will be quantitated in PBMC samples, obtained before adoptive transfer and at weeks 1, 2, 4, 8, and 12 after transgenic cell adoptive transfer. Thereafter, sampling will be every 3 months during the first year, and then every 6 to 12 months per schedule of procedures and observations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearWill be assessed in blood by polymerase chain reaction (PCR).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 90 days after TCR transgenic PBMC adoptive transferWill be determined by immune-related Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Response assessment will be performed by comparing standard computed tomography imaging scans and photographs of target lesions from baseline.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)
n=3 participants at risk
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^7
|
Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)
n=3 participants at risk
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^8
|
Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
n=3 participants at risk
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^9
|
Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
n=6 participants at risk
Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Decitabine: Given IV at 20 mg/m\^2 x 3 days
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^9
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
66.7%
2/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
100.0%
3/3 • Number of events 9 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
16.7%
1/6 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Infections and infestations
Cellulitis
|
33.3%
1/3 • Number of events 2 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
16.7%
1/6 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
16.7%
1/6 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
16.7%
1/6 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
16.7%
1/6 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
Other adverse events
| Measure |
Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)
n=3 participants at risk
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^7
|
Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)
n=3 participants at risk
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^8
|
Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
n=3 participants at risk
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^9
|
Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
n=6 participants at risk
Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Cyclophosphamide: Given IV
Decitabine: Given IV at 20 mg/m\^2 x 3 days
Laboratory Biomarker Analysis: Correlative studies
Leukapheresis: Undergo leukapheresis
TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10\^9
|
|---|---|---|---|---|
|
Surgical and medical procedures
Sinus operation
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
3/3 • Number of events 18 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
66.7%
2/3 • Number of events 18 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
80.0%
4/5 • Number of events 40 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 12 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 8 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Eye disorders
Photopsia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 8 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Abdominal hernia
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Abdominal mass
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 15 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
66.7%
2/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
66.7%
2/3 • Number of events 9 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Number of events 5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Gastric dilatation
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 8 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
66.7%
2/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
66.7%
2/3 • Number of events 9 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
60.0%
3/5 • Number of events 24 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Oesophagitis
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
100.0%
3/3 • Number of events 9 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
66.7%
2/3 • Number of events 12 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Asthenia
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Catheter site pain
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 2 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Early satiety
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Face oedema
|
33.3%
1/3 • Number of events 2 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 12 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
66.7%
2/3 • Number of events 18 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
66.7%
2/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Localised oedema
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Medical device pain
|
33.3%
1/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Oedema
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Oedema peripheral
|
100.0%
3/3 • Number of events 14 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
66.7%
2/3 • Number of events 9 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
66.7%
2/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
40.0%
2/5 • Number of events 8 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
33.3%
1/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Immune system disorders
Cytokine release syndrome
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
60.0%
3/5 • Number of events 12 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Infections and infestations
Cellulitis
|
33.3%
1/3 • Number of events 2 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Infections and infestations
Rhinitis
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
Brain natriuretic peptide increased
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
Cardiac murmur
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
40.0%
2/5 • Number of events 12 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Number of events 9 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 9 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
40.0%
2/5 • Number of events 12 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
Neutrophil count increased
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 18 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
40.0%
2/5 • Number of events 24 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
Platelet count increased
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
Weight increased
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
White blood cell count
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Investigations
White blood cell count decreased
|
100.0%
3/3 • Number of events 26 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
66.7%
2/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
60.0%
3/5 • Number of events 56 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Metabolism and nutrition disorders
Fluid overload
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 8 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
60.0%
3/5 • Number of events 12 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 8 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • Number of events 12 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
66.7%
2/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • Number of events 8 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 11 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
40.0%
2/5 • Number of events 8 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 2 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Psychiatric disorders
Mental status changes
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
2/3 • Number of events 11 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
40.0%
2/5 • Number of events 16 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 8 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 15 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 6 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
20.0%
1/5 • Number of events 4 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
0.00%
0/5 • Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place