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The goal of this study is to determine if the combination of BN-Brachyury plus radiation therapy can induce objective radiographic response rate (ORR) in patients, using a Simon 2-stage optimal design. In stage 1, a minimum of threshold of activity is needed to proceed to stage 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BN-Brachyury plus radiation | Experimental | BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BN-Brachyury plus radiation | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 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%\ | Within 12 months post-completion of radiation on target lesion(s) based on modified RECIST v1.1 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Injection Site Reaction Adverse Events by Preferred Term | Includes Adverse Events that have injection site reactions indicated as the Adverse Event High Level Terms | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Cote, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic, Arizona | Phoenix | Arizona | 85054 | United States | ||
| Mayo Clinic, Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34266694 | Derived | Wedekind MF, Widemann BC, Cote G. Chordoma: Current status, problems, and future directions. Curr Probl Cancer. 2021 Aug;45(4):100771. doi: 10.1016/j.currproblcancer.2021.100771. Epub 2021 Jul 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Full Analysis Set consists of all subjects who have enrolled and received any dose of MVA-BN Brachyury or FPV-Brachyury
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | 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%\ | 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. | Posted | Number | 90% Confidence Interval | percentage of subjects with OR | Within 12 months post-completion of radiation on target lesion(s) based on modified RECIST v1.1 |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bavarian Nordic Call Center | Bavarian Nordic A/S | 1-844-422 | 8274 | medical.information_us@bavarian-nordic.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 22, 2019 | Feb 9, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 2, 2021 | Feb 9, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002817 | Chordoma |
| ID | Term |
|---|---|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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|
| 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. |
| Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores | 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. | 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. |
| Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores | 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. | 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. |
| Frequencies of Participants With Occurrence, Severity and Seriousness of Adverse Events | 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. | 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. |
| Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) | 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. | 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. |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Massachusetts General Hospital, Cancer Center | Boston | Massachusetts | 02114 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Withdrawal by Sponsor |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| HIV Antibody | Count of Participants | Participants |
|
| Hepatitis B Surface | Count of Participants | Participants |
|
| Hepatitis C Virus | Count of Participants | Participants |
|
| ECOG Status | Eastern Cooperative Oncology Group Performance Status. Grade 0 = Fully active, able to carry on all pre-disease performance without restriction. Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours. | Count of Participants | Participants |
|
| Historical Classification | Count of Participants | Participants |
|
| Primary Tumor Site | Count of Participants | Participants |
|
| Disease Status at Diagnosis | Count of Participants | Participants |
|
| Current Disease Status | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
|
|
| Secondary | Progression-free Survival (PFS) | 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. | 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. | Posted | Median | 95% Confidence Interval | Weeks | 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. |
|
|
|
| Secondary | Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. |
|
|
|
| Secondary | Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. |
|
|
|
| Other Pre-specified | Number of Participants With Injection Site Reaction Adverse Events by Preferred Term | Includes Adverse Events that have injection site reactions indicated as the Adverse Event High Level Terms | The Full Analysis Set consists of all subjects who have enrolled and received any dose of MVA-BN Brachyury or FPV-Brachyury | Posted | Count of Participants | Participants | 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. |
|
|
|
| Other Pre-specified | Frequencies of Participants With Occurrence, Severity and Seriousness of Adverse Events | 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. | The Full Analysis Set consists of all subjects who have enrolled and received any dose of MVA-BN Brachyury or FPV-Brachyury. | Posted | Count of Participants | Participants | 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. |
|
|
|
| Other Pre-specified | Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry) | 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. | The Full Analysis Set consists of all subjects who have enrolled and received any dose of MVA-BN Brachyury or FPV-Brachyury. | Posted | Count of Participants | Participants | 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. |
|
|
|
| 2 |
| 29 |
| 8 |
| 29 |
| 29 |
| 29 |
| Sudden death | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Non-systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Injection site discomfort | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Injection site rash | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (21.0) | Non-systematic Assessment |
|
Not provided
|
| Average Pain in the Last Week - Baseline |
|
|
| Pain Right Now - Baseline |
|
|
| Composite Pain Severity Score - Baseline |
|
|
| Composite Pain Interference Score - Baseline |
|
|
| Worst Pain in the Last Week - Overall Treatment Period |
|
|
| Least Pain in the Last Week - Overall Treatment Period |
|
|
| Average Pain in the Last Week - Overall Treatment Period |
|
|
| Pain Right Now - Overall Treatment Period |
|
|
| Composite Pain Severity Score - Overall Treatment Period |
|
|
| Composite Pain Interference Score - Overall Treatment Period |
|
|
| Worst Pain in the Last Week - Change from Baseline in Overall Treatment Period |
|
|
| Least Pain in the Last Week - Change from Baseline in Overall Treatment Period |
|
|
| Average Pain in the Last Week - Change from Baseline in Overall Treatment Period |
|
|
| Pain Right Now - Change from Baseline in Overall Treatment Period |
|
|
| Composite Pain Severity Score - Change from Baseline in Overall Treatment Period |
|
|
| Composite Pain Interference Score - Change from Baseline in Overall Treatment Period |
|
|
|
| Average Pain in the Last Week - Baseline |
|
|
| Pain Right Now - Baseline |
|
|
| Composite Pain Severity Score - Baseline |
|
|
| Composite Pain Interference Score - Baseline |
|
|
| Worst Pain in the Last Week - Overall Treatment Period |
|
|
| Least Pain in the Last Week - Overall Treatment Period |
|
|
| Average Pain in the Last Week - Overall Treatment Period |
|
|
| Pain Right Now - Overall Treatment Period |
|
|
| Composite Pain Severity Score - Overall Treatment Period |
|
|
| Composite Pain Interference Score - Overall Treatment Period |
|
|
| Worst Pain in the Last Week - Change from Baseline in Overall Treatment Period |
|
|
| Least Pain in the Last Week - Change from Baseline in Overall Treatment Period |
|
|
| Average Pain in the Last Week - Change from Baseline in Overall Treatment Period |
|
|
| Pain Right Now - Change from Baseline in Overall Treatment Period |
|
|
| Composite Pain Severity Score - Change from Baseline in Overall Treatment Period |
|
|
| Composite Pain Interference Score - Change from Baseline in Overall Treatment Period |
|
|
| Title | Measurements |
|---|---|
|
| Injection site swelling |
|
| Injection site rash |
|
| Injection site discomfort |
|
| Injection site irritation |
|
| Injection site oedema |
|
| Injection site pruritus |
|
| Title | Measurements |
|---|---|
|
| Severe Related Treatment Emergent Adverse Events |
|
| Serious Adverse Events |
|
| Related Serious Adverse Events |
|
| Adverse Events of Special Interest |
|
| Adverse Events Leading to Discontinuation |
|
| Adverse Events Leading to Death |
|
| Injection Site Reaction Adverse Events |
|
| Leukocytes |
|
| Lymphocytes |
|
| Neutrophils |
|
| Platelets |
|
| Alanine Aminotransferase |
|
| Albumin |
|
| Alkaline Phosphatase |
|
| Aspartate Aminotransferase |
|
| Bilirubin |
|
| Calcium |
|
| Creatinine |
|
| Glucose |
|
| Magnesium |
|
| Phosphate |
|
| Potassium |
|
| Sodium |
|