Trial Outcomes & Findings for Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma (NCT NCT02166463)
NCT ID: NCT02166463
Last Updated: 2026-05-04
Results Overview
Primary analysis will be based 1-sided log rank test comparison of EFS curves between the 2 randomized arms per intention-to-treat principle. Progression is defined as an ≥50% increase of in the product of the perpendicular diameters of any of the involved nodes or nodal masses or focal organ lesions in sites that were persistently PET positive; or recurrent PET positive lesions (Deauville 4, 5) in sites that had previously been PET negative regardless of change of size, as was the development of new PET avid measurable lesion(s) \>1.5cm in any axis, or new sites of assessable disease. Relapse is defined in patients who achieved a prior CR but subsequently has an increase of ≥50% of the PPD in prior nodal or extranodal sites in a recurrently PET positive lesion(s), or the development of new measurable lesion(s) \>1.5cm in any axis, or new sites of assessable disease. Second malignancy is defined based on report of a cancer that is not considered to be classic Hodgkin Lymphoma.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
600 participants
Primary outcome timeframe
Up to 48 months after the last enrollment
Results posted on
2026-05-04
Participant Flow
Participant milestones
| Measure |
Arm I (ABVE-PC)
Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
ARM II (Bv-AVEPC)
Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
300
|
300
|
|
Overall Study
COMPLETED
|
262
|
273
|
|
Overall Study
NOT COMPLETED
|
38
|
27
|
Reasons for withdrawal
| Measure |
Arm I (ABVE-PC)
Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
ARM II (Bv-AVEPC)
Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
10
|
10
|
|
Overall Study
Ineligible
|
11
|
2
|
|
Overall Study
Progressive Disease
|
9
|
6
|
|
Overall Study
Repeat eligibility studies are outside the parameters required for eligibility
|
2
|
2
|
|
Overall Study
Patient enrollment onto another COG study with tumor therapeutic intent
|
1
|
0
|
|
Overall Study
Refusal of further protocol therapy
|
5
|
6
|
Baseline Characteristics
Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Arm I (ABVE-PC)
n=300 Participants
Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
ARM II (Bv-AVEPC)
n=300 Participants
Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
285 Participants
n=54 Participants
|
290 Participants
n=60 Participants
|
575 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=54 Participants
|
10 Participants
n=60 Participants
|
25 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Age, Continuous
|
15.3 years
STANDARD_DEVIATION 3 • n=54 Participants
|
14.8 years
STANDARD_DEVIATION 3.1 • n=60 Participants
|
15 years
STANDARD_DEVIATION 3.1 • n=114 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=54 Participants
|
139 Participants
n=60 Participants
|
281 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
158 Participants
n=54 Participants
|
161 Participants
n=60 Participants
|
319 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
57 Participants
n=54 Participants
|
63 Participants
n=60 Participants
|
120 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
228 Participants
n=54 Participants
|
220 Participants
n=60 Participants
|
448 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=54 Participants
|
17 Participants
n=60 Participants
|
32 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=54 Participants
|
7 Participants
n=60 Participants
|
16 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
5 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=54 Participants
|
34 Participants
n=60 Participants
|
67 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
221 Participants
n=54 Participants
|
224 Participants
n=60 Participants
|
445 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
5 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
34 Participants
n=54 Participants
|
27 Participants
n=60 Participants
|
61 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
281 participants
n=54 Participants
|
277 participants
n=60 Participants
|
558 participants
n=114 Participants
|
|
Region of Enrollment
Canada
|
19 participants
n=54 Participants
|
23 participants
n=60 Participants
|
42 participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Up to 48 months after the last enrollmentPopulation: All the eligible patients who had undergone randomization
Primary analysis will be based 1-sided log rank test comparison of EFS curves between the 2 randomized arms per intention-to-treat principle. Progression is defined as an ≥50% increase of in the product of the perpendicular diameters of any of the involved nodes or nodal masses or focal organ lesions in sites that were persistently PET positive; or recurrent PET positive lesions (Deauville 4, 5) in sites that had previously been PET negative regardless of change of size, as was the development of new PET avid measurable lesion(s) \>1.5cm in any axis, or new sites of assessable disease. Relapse is defined in patients who achieved a prior CR but subsequently has an increase of ≥50% of the PPD in prior nodal or extranodal sites in a recurrently PET positive lesion(s), or the development of new measurable lesion(s) \>1.5cm in any axis, or new sites of assessable disease. Second malignancy is defined based on report of a cancer that is not considered to be classic Hodgkin Lymphoma.
Outcome measures
| Measure |
Arm I (ABVE-PC)
n=289 Participants
Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
ARM II (Bv-AVEPC)
n=298 Participants
Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death
|
82.5 percentage of participants
Interval 77.4 to 86.5
|
92.1 percentage of participants
Interval 88.4 to 94.7
|
SECONDARY outcome
Timeframe: After 42 days of chemotherapyPopulation: All the eligible patients who had undergone randomization and had PET result by central review after completed cycle 2
The percentages of patients (with available PET scan) with no SRL and no PD will be compared between the two randomized arms to see if brentuximab vedotin in the chemotherapy backbone of doxorubicin hydrochloride, vincristine sulfate, etoposide, prednisone and cyclophosphamide (Bv-AVEPC) arm has a higher rate of early response compared to doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide (ABVE-PC) arm. Two-sample Z test of proportions at 1-sided alpha level of 0.05 will be used for these comparisons.
Outcome measures
| Measure |
Arm I (ABVE-PC)
n=285 Participants
Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
ARM II (Bv-AVEPC)
n=292 Participants
Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review
|
80.7 Percentage of patients
Interval 76.1 to 85.3
|
81.2 Percentage of patients
Interval 76.7 to 85.7
|
SECONDARY outcome
Timeframe: From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.Population: All the eligible patients who had undergone randomization
The percentages of patients experiencing grade 3+ peripheral neuropathy assessed by the treating clinician using the modified Balis scale. The "Modified Balis scale of Pediatric Neuropathy" allows clinicians to assign a score for sensory or motor neuropathy symptoms separately. Scores range from 1 to 4 with 1 being the least symptomatic state and 4 indicating a severe debility. The percentages of patients (with a score \>/=3) will be compared between the 2 arms by two-sample Z test at 1-sided alpha level of 0.05.
Outcome measures
| Measure |
Arm I (ABVE-PC)
n=289 Participants
Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
ARM II (Bv-AVEPC)
n=298 Participants
Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale
|
5.5 Percentage of patients
Interval 2.9 to 8.17
|
6.7 Percentage of patients
Interval 3.87 to 9.55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineCHIPS will be computed for all patients and summarized by descriptive statistics. Will examine the association between CHIPS and early response by cross-tabulations and Chi-square tests within each arm separately, as well as logistic regression model where early response is the outcome variable and CHIPS the predictor variable combining the 2 arms with adjustment for randomized chemotherapy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 48 monthsDescriptive statistics will be used to summarize RT doses received by normal tissues on this study. Two-sample t-test will be used to compare the doses received on this study to those on prior studies.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsEFS for patients on each arm as well as those receiving ISRT or those with slow early response (SER) on each arm will be estimated. One-sample log rank test will be used to compare the observed EFS to the assumed baseline of 82% at 3 years to see if the observed EFS is significantly lower than the projection in these subsets.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 48 months after the last enrollmentThe risk of relapse for cases that are RRL, but have Deauville 3 lesions, will be compared to those that are classified as complete metabolic response at PET2 with solely Deauville 1 or 2 lesions with K-sample test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose and end of infusion on day 1, days 2, 3, 8, and 15 of cycle 4 and pre-dose on day 1 and day 22 of cycle 5 (each cycle = 21 days)PK concentration time profile will be evaluated.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (ABVE-PC)
Serious events: 11 serious events
Other events: 206 other events
Deaths: 4 deaths
ARM II (Bv-AVEPC)
Serious events: 66 serious events
Other events: 209 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm I (ABVE-PC)
n=287 participants at risk
Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
ARM II (Bv-AVEPC)
n=295 participants at risk
Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
4/287 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
3.1%
9/295 • Number of events 9 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Cardiac disorders
Sinus tachycardia
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
2.0%
6/295 • Number of events 6 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
2.0%
6/295 • Number of events 6 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Rectal mucositis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.4%
4/295 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
General disorders
Chills
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
General disorders
Fatigue
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
General disorders
Fever
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
General disorders
Multi-organ failure
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
General disorders
Pain
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Immune system disorders
Allergic reaction
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Immune system disorders
Anaphylaxis
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Bone infection
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Lung infection
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Sepsis
|
1.7%
5/287 • Number of events 5 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
2.0%
6/295 • Number of events 6 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Skin infection
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Creatinine increased
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Lipase increased
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.4%
4/295 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Platelet count decreased
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Serum amylase increased
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
White blood cell decreased
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
2.0%
6/295 • Number of events 6 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.7%
5/295 • Number of events 5 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.4%
4/295 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.4%
4/295 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Headache
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.4%
4/295 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
2.0%
6/295 • Number of events 6 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Seizure
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Syncope
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Vascular disorders
Hypertension
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Vascular disorders
Hypotension
|
1.4%
4/287 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
3.4%
10/295 • Number of events 10 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
3.1%
9/295 • Number of events 9 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
Other adverse events
| Measure |
Arm I (ABVE-PC)
n=287 participants at risk
Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
ARM II (Bv-AVEPC)
n=295 participants at risk
Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
31.0%
89/287 • Number of events 89 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
36.3%
107/295 • Number of events 107 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
31.4%
90/287 • Number of events 90 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
28.1%
83/295 • Number of events 83 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Cardiac disorders
Sinus tachycardia
|
1.4%
4/287 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Eye disorders
Blurred vision
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
8/287 • Number of events 8 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Anal fistula
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Colitis
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Constipation
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.7%
5/295 • Number of events 5 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Dental caries
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Diarrhea
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
2.0%
6/295 • Number of events 6 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Dysphagia
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Esophagitis
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.7%
22/287 • Number of events 22 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
9.5%
28/295 • Number of events 28 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
6/287 • Number of events 6 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
3.4%
10/295 • Number of events 10 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Oral pain
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.4%
4/295 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Rectal mucositis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Rectal pain
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Typhlitis
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
4/287 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
3.7%
11/295 • Number of events 11 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
General disorders
Fever
|
2.1%
6/287 • Number of events 6 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
General disorders
Non-cardiac chest pain
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
General disorders
Pain
|
1.0%
3/287 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.4%
4/295 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Immune system disorders
Allergic reaction
|
5.2%
15/287 • Number of events 15 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
2.4%
7/295 • Number of events 7 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Immune system disorders
Anaphylaxis
|
3.5%
10/287 • Number of events 10 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
2.4%
7/295 • Number of events 7 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Appendicitis
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Arteritis infective
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Catheter related infection
|
1.4%
4/287 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Enterocolitis infectious
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.4%
4/295 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Gum infection
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.4%
4/287 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
2.4%
7/295 • Number of events 7 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Infective myositis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Lung infection
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Meningitis
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Otitis media
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Sepsis
|
2.4%
7/287 • Number of events 7 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Shingles
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Skin infection
|
1.4%
4/287 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.4%
4/295 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Soft tissue infection
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Thrush
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Urinary tract infection
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Vaginal infection
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Vulval infection
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Infections and infestations
Wound infection
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.8%
8/287 • Number of events 8 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.4%
4/287 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Alanine aminotransferase increased
|
3.5%
10/287 • Number of events 10 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
3.7%
11/295 • Number of events 11 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Aspartate aminotransferase increased
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Blood bilirubin increased
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
GGT increased
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Lipase increased
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Lymphocyte count decreased
|
26.1%
75/287 • Number of events 75 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
24.1%
71/295 • Number of events 71 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Lymphocyte count increased
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Neutrophil count decreased
|
40.4%
116/287 • Number of events 116 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
48.8%
144/295 • Number of events 144 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Platelet count decreased
|
28.2%
81/287 • Number of events 81 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
32.2%
95/295 • Number of events 95 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Serum amylase increased
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Vital capacity abnormal
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Weight gain
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
Weight loss
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Investigations
White blood cell decreased
|
35.9%
103/287 • Number of events 103 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
41.0%
121/295 • Number of events 121 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
5/287 • Number of events 5 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
2.7%
8/295 • Number of events 8 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
3/287 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.4%
4/295 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.4%
4/287 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.4%
4/295 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.4%
4/287 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.4%
4/287 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.7%
5/295 • Number of events 5 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.6%
19/287 • Number of events 19 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
4.4%
13/295 • Number of events 13 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.1%
9/287 • Number of events 9 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
2.7%
8/295 • Number of events 8 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.4%
4/287 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
2.0%
6/295 • Number of events 6 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.4%
4/287 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.7%
5/295 • Number of events 5 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
3/287 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Aphonia
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Headache
|
1.7%
5/287 • Number of events 5 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Paresthesia
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
9.8%
28/287 • Number of events 28 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
4.4%
13/295 • Number of events 13 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.0%
43/287 • Number of events 43 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
14.2%
42/295 • Number of events 42 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Recurrent laryngeal nerve palsy
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Seizure
|
1.0%
3/287 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Nervous system disorders
Syncope
|
2.8%
8/287 • Number of events 8 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.68%
2/295 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Psychiatric disorders
Insomnia
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Renal and urinary disorders
Hematuria
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Reproductive system and breast disorders
Penile pain
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Reproductive system and breast disorders
Premature menopause
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.70%
2/287 • Number of events 2 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/287 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Vascular disorders
Hematoma
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.00%
0/295 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Vascular disorders
Hypertension
|
0.35%
1/287 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.0%
3/295 • Number of events 3 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
|
Vascular disorders
Hypotension
|
3.8%
11/287 • Number of events 11 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
0.34%
1/295 • Number of events 1 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
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Vascular disorders
Thromboembolic event
|
2.1%
6/287 • Number of events 6 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
|
1.4%
4/295 • Number of events 4 • From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
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Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60