Trial Outcomes & Findings for BN Brachyury and Radiation in Chordoma (NCT NCT03595228)

NCT ID: NCT03595228

Last Updated: 2023-04-14

Results Overview

Rate of subjects achieving a best response of either Complete Response or Partial Response per modified RECIST v1.1. A modified RECIST v1.1 assessment is based on targeted radiated lesion(s). Progression of a non-target lesion does not result in disease progression by the modified RECIST evaluation for this trial. Assessment for targeted radiated lesion(s): Complete Response (CR)=Disappearance of all target radiated lesions; Partial Response (PR)= \>=30% decrease in the sum of the longest diameter of target radiated lesions; Progressive Disease (PD) = \>=20% increase in the sum of the longest diameter of target radiated lesions, Stable Disease (SD)=-30%\<sum of the longest diameter of target radiated lesions\<20%.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: Within 12 months post-completion of radiation on target lesion(s) based on modified RECIST v1.1
• Results posted on: 2023-04-14

Participant Flow

Participant milestones

Measure	BN-Brachyury Plus Radiation BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury BN-Brachyury plus radiation: MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.
Overall Study STARTED	29
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Measure	BN-Brachyury Plus Radiation BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury BN-Brachyury plus radiation: MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.
Overall Study Death	2
Overall Study Lack of Efficacy	13
Overall Study Withdrawal by Subject	3
Overall Study Withdrawal by Sponsor	1

Baseline Characteristics

BN Brachyury and Radiation in Chordoma

Baseline characteristics by cohort

Measure	BN-Brachyury Plus Radiation n=29 Participants BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury BN-Brachyury plus radiation: MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants
Age, Continuous	65.9 years STANDARD_DEVIATION 10.82 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants
HIV Antibody Positive	0 Participants n=5 Participants
HIV Antibody Negative	29 Participants n=5 Participants
Hepatitis B Surface Positive	0 Participants n=5 Participants
Hepatitis B Surface Negative	29 Participants n=5 Participants
Hepatitis C Virus Positive	0 Participants n=5 Participants
Hepatitis C Virus Negative	29 Participants n=5 Participants
ECOG Status 0	12 Participants n=5 Participants
ECOG Status 1	17 Participants n=5 Participants
ECOG Status 2	0 Participants n=5 Participants
Historical Classification Classical	26 Participants n=5 Participants
Historical Classification Chondroid	0 Participants n=5 Participants
Historical Classification Not Reported	3 Participants n=5 Participants
Primary Tumor Site Clival	3 Participants n=5 Participants
Primary Tumor Site Mobile Spine	8 Participants n=5 Participants
Primary Tumor Site Sacral	18 Participants n=5 Participants
Disease Status at Diagnosis Localized	20 Participants n=5 Participants
Disease Status at Diagnosis Locally Advanced	7 Participants n=5 Participants
Disease Status at Diagnosis Metastatic	2 Participants n=5 Participants
Current Disease Status Localized	0 Participants n=5 Participants
Current Disease Status Locally Advanced	5 Participants n=5 Participants
Current Disease Status Metastatic	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 12 months post-completion of radiation on target lesion(s) based on modified RECIST v1.1

Population: Evaluable Analysis Set conisits of subjects who have completed two prime doses of MVA-BN-Brachyury and one booster dose of FPV-Brachyury prior to radiation, have completed radiation therapy, have at least 3 out of 4 booster doses of FPV-Brachyury in 14 weeks after radation, have both baseline and at least one post-baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan for objective tumor evaluation.

Rate of subjects achieving a best response of either Complete Response or Partial Response per modified RECIST v1.1. A modified RECIST v1.1 assessment is based on targeted radiated lesion(s). Progression of a non-target lesion does not result in disease progression by the modified RECIST evaluation for this trial. Assessment for targeted radiated lesion(s): Complete Response (CR)=Disappearance of all target radiated lesions; Partial Response (PR)= >=30% decrease in the sum of the longest diameter of target radiated lesions; Progressive Disease (PD) = >=20% increase in the sum of the longest diameter of target radiated lesions, Stable Disease (SD)=-30%<sum of the longest diameter of target radiated lesions<20%.

Outcome measures

Measure

BN-Brachyury Plus Radiation n=26 Participants BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury BN-Brachyury plus radiation: MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.

Objective Response Rate (ORR)

7.7 percentage of subjects with OR Interval 2.6 to 20.8

SECONDARY outcome

Timeframe: Time from the day of first treatment to the start of disease progression or death, whichever occurs first up to 30 days after last tumor assessment visit. Data were collected up to 29 months.

Population: Evaluable Analysis Set consists of subjects who have completed two prime doses of MVA-BN-Brachyury and one booster dose of FPV-Brachyury prior to radiation, have completed radiation therapy, have at least 3 out of 4 booster doses of FPV-Brachyury in 14 weeks after radation, have both baseline and at least one post-baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan for objective tumor evaluation.

Kaplan-Meier of the time interval from first treatment to objective tumor progression based on modified RECIST v1.1 or death. A modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) based on targeted radiated lesion(s) will be used. Progression will be defined as a 20% increase in the sum of the longest diameter of target radiated lesions in this trial, and a progression of a non-target lesion does not result in disease progression by the modified RECIST evaluation used for this trial.

Outcome measures

Measure

BN-Brachyury Plus Radiation n=26 Participants BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury BN-Brachyury plus radiation: MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.

Progression-free Survival (PFS)

NA Weeks Interval 51.29 to It is NA because there are insufficient number of participants with events and hence median and upper 95% confidence interval are not evaluable.

SECONDARY outcome

Timeframe: Overall Treatment Period: The time from the day of first treatment to the last scheduled trial visit, approximately 30 days after the last treatment visit. Data were collected up to 29 months.

Population: Evaluable Analysis Set consists of subjects who have completed two prime doses of MVA-BN-Brachyury and one booster dose of FPV-Brachyury prior to radiation, have completed radiation therapy, have at least 3 out of 4 booster doses of FPV-Brachyury in 14 weeks after radiation, have both baseline and at least one post-baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan for objective tumor evaluation.

Pain intensity and pain interference scores are summarized. Pain intensity scores includes pain items "Worst Pain in the Last Week", "Least Pain in the Last Week", and "Average Pain in the Last Week" and "Pain Right Now". Composite pain severity score (a mean severity score of the four pain items listed before). Composite pain interference score (a mean of the seven interference items). This will be calculated if at least four of the seven interference items have been completed on a given administration. Pain scores range from 0 to 10 with a score of 10 is the worst pain imaginable and a score of 0 is no pain. Best observed scores is the lowest score value observed.

Outcome measures

Measure	BN-Brachyury Plus Radiation n=26 Participants BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury BN-Brachyury plus radiation: MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Composite Pain Severity Score - Change from Baseline in Overall Treatment Period	-0.75 score on a scale Standard Deviation 1.0577
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Composite Pain Interference Score - Change from Baseline in Overall Treatment Period	-1.127 score on a scale Standard Deviation 1.4096
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Worst Pain in the Last Week - Baseline	4 score on a scale Standard Deviation 3.46
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Least Pain in the Last Week - Baseline	1.5 score on a scale Standard Deviation 1.81
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Average Pain in the Last Week - Baseline	2.4 score on a scale Standard Deviation 2.13
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Pain Right Now - Baseline	2 score on a scale Standard Deviation 1.99
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Composite Pain Severity Score - Baseline	2.476 score on a scale Standard Deviation 2.1779
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Composite Pain Interference Score - Baseline	2.869 score on a scale Standard Deviation 2.7136
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Worst Pain in the Last Week - Overall Treatment Period	2.3 score on a scale Standard Deviation 1.0
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Least Pain in the Last Week - Overall Treatment Period	0.8 score on a scale Standard Deviation 0.91
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Average Pain in the Last Week - Overall Treatment Period	1.5 score on a scale Standard Deviation 1.53
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Pain Right Now - Overall Treatment Period	1.2 score on a scale Standard Deviation 1.43
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Composite Pain Severity Score - Overall Treatment Period	1.625 score on a scale Standard Deviation 1.6737
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Composite Pain Interference Score - Overall Treatment Period	1.451 score on a scale Standard Deviation 2.0962
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Worst Pain in the Last Week - Change from Baseline in Overall Treatment Period	-1.4 score on a scale Standard Deviation 1.75
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Least Pain in the Last Week - Change from Baseline in Overall Treatment Period	-0.7 score on a scale Standard Deviation 1.35
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Average Pain in the Last Week - Change from Baseline in Overall Treatment Period	-0.8 score on a scale Standard Deviation 1.03
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores Pain Right Now - Change from Baseline in Overall Treatment Period	-0.8 score on a scale Standard Deviation 0.81

SECONDARY outcome

Timeframe: Overall Treatment Period: The time from the day of first treatment to the last scheduled trial visit, approximately 30 days after the last treatment visit. Data were collected up to 29 months.

Population: Evaluable Analysis Set consists of subjects who have completed two prime doses of MVA-BN-Brachyury and one booster dose of FPV-Brachyury prior to radiation, have completed radiation therapy, have at least 3 out of 4 booster doses of FPV-Brachyury in 14 weeks after radiation, have both baseline and at least one post-baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan for objective tumor evaluation.

Pain intensity and pain interference scores are summarized. Pain intensity scores includes pain items "Worst Pain in the Last Week", "Least Pain in the Last Week", and "Average Pain in the Last Week" and "Pain Right Now". Composite pain severity score (a mean severity score of the four pain items listed before). Composite pain interference score (a mean of the seven interference items). This will be calculated if at least four of the seven interference items have been completed on a given administration. Pain scores range from 0 to 10 with a score of 10 is the worst pain imaginable and a score of 0 is no pain. Worst observed scores is the highest score value observed.

Outcome measures

Measure	BN-Brachyury Plus Radiation n=26 Participants BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury BN-Brachyury plus radiation: MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Least Pain in the Last Week - Baseline	1.5 score on a scale Standard Deviation 1.81
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Worst Pain in the Last Week - Baseline	4.0 score on a scale Standard Deviation 3.46
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Average Pain in the Last Week - Baseline	2.4 score on a scale Standard Deviation 2.13
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Pain Right Now - Baseline	2.0 score on a scale Standard Deviation 1.99
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Composite Pain Severity Score - Baseline	2.476 score on a scale Standard Deviation 2.1779
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Composite Pain Interference Score - Baseline	2.869 score on a scale Standard Deviation 2.7136
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Worst Pain in the Last Week - Overall Treatment Period	6.7 score on a scale Standard Deviation 2.88
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Least Pain in the Last Week - Overall Treatment Period	3.9 score on a scale Standard Deviation 2.77
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Average Pain in the Last Week - Overall Treatment Period	4.9 score on a scale Standard Deviation 2.57
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Pain Right Now - Overall Treatment Period	5.1 score on a scale Standard Deviation 2.59
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Composite Pain Severity Score - Overall Treatment Period	4.885 score on a scale Standard Deviation 2.4374
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Composite Pain Interference Score - Overall Treatment Period	5.028 score on a scale Standard Deviation 2.9807
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Worst Pain in the Last Week - Change from Baseline in Overall Treatment Period	2.4 score on a scale Standard Deviation 3.31
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Least Pain in the Last Week - Change from Baseline in Overall Treatment Period	2.0 score on a scale Standard Deviation 2.73
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Average Pain in the Last Week - Change from Baseline in Overall Treatment Period	2.2 score on a scale Standard Deviation 2.59
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Pain Right Now - Change from Baseline in Overall Treatment Period	2.9 score on a scale Standard Deviation 2.69
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Composite Pain Severity Score - Change from Baseline in Overall Treatment Period	2.179 score on a scale Standard Deviation 2.6317
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores Composite Pain Interference Score - Change from Baseline in Overall Treatment Period	2.152 score on a scale Standard Deviation 2.9053

OTHER_PRE_SPECIFIED outcome

Timeframe: All AEs that are presented during or following initiation of trial treatment or worsens in severity are collected through the last scheduled visit (approximately 30 days after the last dose of treatment). Data were collected up to 29 months.

Population: The Full Analysis Set consists of all subjects who have enrolled and received any dose of MVA-BN Brachyury or FPV-Brachyury

Includes Adverse Events that have injection site reactions indicated as the Adverse Event High Level Terms

Outcome measures

Measure	BN-Brachyury Plus Radiation n=29 Participants BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury BN-Brachyury plus radiation: MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.
Number of Participants With Injection Site Reaction Adverse Events by Preferred Term Injection site pain	16 Participants
Number of Participants With Injection Site Reaction Adverse Events by Preferred Term Injection site erythema	6 Participants
Number of Participants With Injection Site Reaction Adverse Events by Preferred Term Injection site induration	4 Participants
Number of Participants With Injection Site Reaction Adverse Events by Preferred Term Injection site swelling	4 Participants
Number of Participants With Injection Site Reaction Adverse Events by Preferred Term Injection site rash	3 Participants
Number of Participants With Injection Site Reaction Adverse Events by Preferred Term Injection site discomfort	2 Participants
Number of Participants With Injection Site Reaction Adverse Events by Preferred Term Injection site irritation	1 Participants
Number of Participants With Injection Site Reaction Adverse Events by Preferred Term Injection site oedema	1 Participants
Number of Participants With Injection Site Reaction Adverse Events by Preferred Term Injection site pruritus	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: All AEs that are presented during or following initiation of trial treatment or worsens in severity are collected through the last scheduled visit (approximately 30 days after the last dose of treatment). Data were collected up to 29 months.

Population: The Full Analysis Set consists of all subjects who have enrolled and received any dose of MVA-BN Brachyury or FPV-Brachyury.

Occurrence is defined as the number of participants who experienced an AE. Related SAEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per CTCAE v4.03 grade.

Outcome measures

Measure	BN-Brachyury Plus Radiation n=29 Participants BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury BN-Brachyury plus radiation: MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.
Frequencies of Participants With Occurrence, Severity and Seriousness of Adverse Events Treatment Emergent Adverse Events	29 Participants
Frequencies of Participants With Occurrence, Severity and Seriousness of Adverse Events Related Treatment Emergent Adverse Events	28 Participants
Frequencies of Participants With Occurrence, Severity and Seriousness of Adverse Events Severe Treatment Emergent Adverse Events	11 Participants
Frequencies of Participants With Occurrence, Severity and Seriousness of Adverse Events Severe Related Treatment Emergent Adverse Events	3 Participants
Frequencies of Participants With Occurrence, Severity and Seriousness of Adverse Events Serious Adverse Events	8 Participants
Frequencies of Participants With Occurrence, Severity and Seriousness of Adverse Events Related Serious Adverse Events	2 Participants
Frequencies of Participants With Occurrence, Severity and Seriousness of Adverse Events Adverse Events of Special Interest	1 Participants
Frequencies of Participants With Occurrence, Severity and Seriousness of Adverse Events Adverse Events Leading to Discontinuation	1 Participants
Frequencies of Participants With Occurrence, Severity and Seriousness of Adverse Events Adverse Events Leading to Death	1 Participants
Frequencies of Participants With Occurrence, Severity and Seriousness of Adverse Events Injection Site Reaction Adverse Events	24 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Overall Treatment Period: The time from the day of first treatment to the last scheduled trial visit, approximately 30 days after the last treatment visit. Data were collected up to 29 months.

Population: The Full Analysis Set consists of all subjects who have enrolled and received any dose of MVA-BN Brachyury or FPV-Brachyury.

For hematology and chemistry laboratory parameters with CTCAE grading scales, toxicity grade shift is defined to evaluated categorical changes from baseline results to post-treatment results with respect to dichotomized CTCAE grading value (<= Grade 2, >= Grade 3). Grade 0=No adverse event or within normal limits; Grade 1=Mild adverse event; Grade 2=Moderate adverse event; Grade 3=Severe and undesirable adverse event; Grade 4=Life-threatening or disabling adverse event; Grade 5=Death related to adverse event. Higher scores mean worse outcome.

Outcome measures

Measure	BN-Brachyury Plus Radiation n=29 Participants BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury BN-Brachyury plus radiation: MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Hemoglobin · <= Grade 2	29 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Hemoglobin · >= Grade 3	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Hemoglobin · Missing	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Leukocytes · <= Grade 2	29 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Leukocytes · >= Grade 3	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Leukocytes · Missing	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Lymphocytes · <= Grade 2	23 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Lymphocytes · >= Grade 3	6 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Lymphocytes · Missing	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Neutrophils · <= Grade 2	29 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Neutrophils · >= Grade 3	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Neutrophils · Missing	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Platelets · <= Grade 2	29 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Platelets · >= Grade 3	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Platelets · Missing	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Alanine Aminotransferase · <= Grade 2	29 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Alanine Aminotransferase · >= Grade 3	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Alanine Aminotransferase · Missing	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Albumin · <= Grade 2	29 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Albumin · >= Grade 3	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Albumin · Missing	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Alkaline Phosphatase · <= Grade 2	29 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Alkaline Phosphatase · >= Grade 3	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Alkaline Phosphatase · Missing	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Aspartate Aminotransferase · <= Grade 2	29 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Aspartate Aminotransferase · >= Grade 3	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Aspartate Aminotransferase · Missing	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Bilirubin · <= Grade 2	29 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Bilirubin · >= Grade 3	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Bilirubin · Missing	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Calcium · <= Grade 2	29 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Calcium · >= Grade 3	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Calcium · Missing	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Creatinine · <= Grade 2	29 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Creatinine · >= Grade 3	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Creatinine · Missing	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Glucose · <= Grade 2	27 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Glucose · >= Grade 3	2 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Glucose · Missing	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Magnesium · <= Grade 2	15 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Magnesium · >= Grade 3	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Magnesium · Missing	14 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Phosphate · <= Grade 2	15 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Phosphate · >= Grade 3	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Phosphate · Missing	14 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Potassium · <= Grade 2	29 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Potassium · >= Grade 3	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Potassium · Missing	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Sodium · <= Grade 2	29 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Sodium · >= Grade 3	0 Participants
Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) Sodium · Missing	0 Participants

Adverse Events

BN-Brachyury Plus Radiation

Serious events: 8 serious events

Other events: 29 other events

Deaths: 2 deaths

Serious adverse events

Measure	BN-Brachyury Plus Radiation n=29 participants at risk BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury BN-Brachyury plus radiation: MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.
Gastrointestinal disorders Small intestinal obstruction	3.4% 1/29 • Number of events 1 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
General disorders Sudden death	3.4% 1/29 • Number of events 1 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Infections and infestations Sepsis	3.4% 1/29 • Number of events 1 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Infections and infestations Wound infection	3.4% 1/29 • Number of events 1 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Injury, poisoning and procedural complications Thermal burn	3.4% 1/29 • Number of events 1 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	6.9% 2/29 • Number of events 2 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Nervous system disorders Cerebral ischaemia	3.4% 1/29 • Number of events 2 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Nervous system disorders Seizure	3.4% 1/29 • Number of events 1 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.

Other adverse events

Measure	BN-Brachyury Plus Radiation n=29 participants at risk BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury BN-Brachyury plus radiation: MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.
Blood and lymphatic system disorders Anaemia	6.9% 2/29 • Number of events 2 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Gastrointestinal disorders Abdominal pain	10.3% 3/29 • Number of events 3 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Gastrointestinal disorders Constipation	6.9% 2/29 • Number of events 2 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Gastrointestinal disorders Diarrhoea	13.8% 4/29 • Number of events 5 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Gastrointestinal disorders Nausea	27.6% 8/29 • Number of events 9 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Gastrointestinal disorders Vomiting	17.2% 5/29 • Number of events 5 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
General disorders Chills	27.6% 8/29 • Number of events 10 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
General disorders Fatigue	55.2% 16/29 • Number of events 21 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
General disorders Influenza like illness	13.8% 4/29 • Number of events 5 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
General disorders Injection site discomfort	6.9% 2/29 • Number of events 2 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
General disorders Injection site erythema	20.7% 6/29 • Number of events 7 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
General disorders Injection site induration	13.8% 4/29 • Number of events 5 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
General disorders Injection site pain	55.2% 16/29 • Number of events 24 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
General disorders Injection site rash	10.3% 3/29 • Number of events 22 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
General disorders Injection site swelling	13.8% 4/29 • Number of events 5 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
General disorders Oedema peripheral	10.3% 3/29 • Number of events 3 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
General disorders Pain	10.3% 3/29 • Number of events 4 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
General disorders Pyrexia	17.2% 5/29 • Number of events 7 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Infections and infestations Urinary tract infection	17.2% 5/29 • Number of events 6 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Injury, poisoning and procedural complications Radiation skin injury	27.6% 8/29 • Number of events 8 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Investigations Weight decreased	20.7% 6/29 • Number of events 6 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Metabolism and nutrition disorders Decreased appetite	10.3% 3/29 • Number of events 3 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Metabolism and nutrition disorders Dehydration	6.9% 2/29 • Number of events 2 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Metabolism and nutrition disorders Hypophosphataemia	6.9% 2/29 • Number of events 2 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Musculoskeletal and connective tissue disorders Arthralgia	6.9% 2/29 • Number of events 2 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Musculoskeletal and connective tissue disorders Back pain	17.2% 5/29 • Number of events 6 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Musculoskeletal and connective tissue disorders Flank pain	6.9% 2/29 • Number of events 2 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Musculoskeletal and connective tissue disorders Muscular weakness	10.3% 3/29 • Number of events 3 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	6.9% 2/29 • Number of events 2 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	13.8% 4/29 • Number of events 4 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Musculoskeletal and connective tissue disorders Myalgia	10.3% 3/29 • Number of events 5 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Musculoskeletal and connective tissue disorders Neck pain	6.9% 2/29 • Number of events 2 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Musculoskeletal and connective tissue disorders Pain in extremity	13.8% 4/29 • Number of events 4 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Nervous system disorders Dizziness	24.1% 7/29 • Number of events 7 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Nervous system disorders Dysgeusia	10.3% 3/29 • Number of events 4 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Nervous system disorders Headache	24.1% 7/29 • Number of events 10 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Nervous system disorders Neuralgia	6.9% 2/29 • Number of events 2 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Psychiatric disorders Insomnia	6.9% 2/29 • Number of events 2 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Renal and urinary disorders Dysuria	6.9% 2/29 • Number of events 2 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Respiratory, thoracic and mediastinal disorders Cough	13.8% 4/29 • Number of events 4 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.3% 3/29 • Number of events 3 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Skin and subcutaneous tissue disorders Rash	13.8% 4/29 • Number of events 9 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	10.3% 3/29 • Number of events 4 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Vascular disorders Hypertension	10.3% 3/29 • Number of events 3 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.
Vascular disorders Hypotension	10.3% 3/29 • Number of events 3 • All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months. All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.

Additional Information

Bavarian Nordic Call Center

Bavarian Nordic A/S

Phone: 1-844-422

Email: medical.information_us@bavarian-nordic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60