Trial Outcomes & Findings for Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza (NCT NCT05170009)

NCT ID: NCT05170009

Last Updated: 2025-02-26

Results Overview

Influenza viral RNA loads will be measured by quantitative real time polymerase chain reaction.

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 2 participants
• Primary outcome timeframe: Baseline; Day 10
• Results posted on: 2025-02-26

Participant Flow

Recruitment for this study was challenging because of changed flu seasonality and low flu cases following covid-19

Participant milestones

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Overall Study STARTED	0	2
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Overall Study Physician Decision	0	1

Baseline Characteristics

Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza

Baseline characteristics by cohort

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=2 Participants Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Total n=2 Participants Total of all reporting groups
Age, Continuous	—	45 years STANDARD_DEVIATION 30 • n=7 Participants	45 years STANDARD_DEVIATION 30 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline; Day 10

Population: The only patient that completed the study, was randomized into the placebo arm.

Influenza viral RNA loads will be measured by quantitative real time polymerase chain reaction.

Outcome measures

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=1 Participants Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Quantitative Real Time Polymerase Chain Reaction. Baseline	—	2300000 copies per mL
Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Quantitative Real Time Polymerase Chain Reaction. Day 10	—	0 copies per mL

PRIMARY outcome

Timeframe: Baseline; Day 10

Population: The only patient that completed the study, was randomized into the placebo arm. Difference cannot be calculated as one arm has zero patients.

Influenza viral load will be measured by the quantitative real time polymerase chain reaction.

Outcome measures

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=1 Participants Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Between-treatment-arm Difference in the Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Quantitative Real Time Polymerase Chain Reaction. Baseline	—	2300000 copies per mL
Between-treatment-arm Difference in the Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Quantitative Real Time Polymerase Chain Reaction. Day 10	—	0 copies per mL

PRIMARY outcome

Timeframe: Baseline; Day 10

Population: The only patient that completed the study, was randomized into the placebo arm. Difference cannot be calculated as one arm has zero patients.

Influenza viral load will be measured by the influenza plaque assay.

Outcome measures

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=1 Participants Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Between-treatment-arm Difference in the Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Influenza Plaque Assay (Replicating Virus). Baseline	—	2300000 PFU per mL
Between-treatment-arm Difference in the Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Influenza Plaque Assay (Replicating Virus). Day 10	—	0 PFU per mL

SECONDARY outcome

Timeframe: Baseline; Day 4; Day 7; Day 10

Population: The only patient that completed the study, was randomized into the placebo arm.

Influenza viral RNA load will be measured by quantitative real time polymerase chain reaction.

Outcome measures

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=1 Participants Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Change of Influenza Viral RNA Load From Baseline at Day 4 and Day 7 and 10 in Each Treatment Arm Day 10	—	0 copies per mL
Change of Influenza Viral RNA Load From Baseline at Day 4 and Day 7 and 10 in Each Treatment Arm Baseline	—	2300000 copies per mL
Change of Influenza Viral RNA Load From Baseline at Day 4 and Day 7 and 10 in Each Treatment Arm Day 4	—	800 copies per mL
Change of Influenza Viral RNA Load From Baseline at Day 4 and Day 7 and 10 in Each Treatment Arm Day 7	—	1300 copies per mL

SECONDARY outcome

Timeframe: Baseline; Day 4; Day 7; Day 10

Population: The only patient that completed the study, was randomized into the placebo arm. Difference cannot be calculated as one arm has zero patients.

Influenza viral RNA load will be measured by quantitative real time polymerase chain reaction.

Outcome measures

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=1 Participants Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Quantitative Real Time Polymerase Chain Reaction Baseline	—	2300000 copies per mL
Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Quantitative Real Time Polymerase Chain Reaction Day 4	—	800 copies per mL
Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Quantitative Real Time Polymerase Chain Reaction Day 7	—	1300 copies per mL
Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Quantitative Real Time Polymerase Chain Reaction Day 10	—	0 copies per mL

SECONDARY outcome

Timeframe: Baseline; Day 4; Day 7; Day 10

Population: The only patient that completed the study, was randomized into the placebo arm.

Influenza viral load will be measured by the influenza plaque assay (replicating virus).

Outcome measures

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=1 Participants Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 as Measured by Influenza Plaque Assay (Replicating Virus) in Each Treatment Arm Baseline	—	2300000 PFU per mL
Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 as Measured by Influenza Plaque Assay (Replicating Virus) in Each Treatment Arm Day 4	—	800 PFU per mL
Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 as Measured by Influenza Plaque Assay (Replicating Virus) in Each Treatment Arm Day 7	—	1300 PFU per mL
Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 as Measured by Influenza Plaque Assay (Replicating Virus) in Each Treatment Arm Day 10	—	0 PFU per mL

SECONDARY outcome

Timeframe: Baseline; Day 4; Day 7; Day 10

Population: The only patient that completed the study, was randomized into the placebo arm. Difference cannot be calculated as one arm has zero patients.

Influenza viral load will be measured by the influenza plaque assay (replicating virus).

Outcome measures

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=1 Participants Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Influenza Plaque Assay (Replicating Virus) Baseline	—	2300000 PFU per mL
Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Influenza Plaque Assay (Replicating Virus) Day 4	—	800 PFU per mL
Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Influenza Plaque Assay (Replicating Virus) Day 10	—	0 PFU per mL
Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Influenza Plaque Assay (Replicating Virus) Day 7	—	1300 PFU per mL

SECONDARY outcome

Timeframe: Baseline to Day 30

Population: The only patient that completed the study, was randomized into the placebo arm.

Patients will self-assess the severity of 7 influenza-associated symptoms on a 4-point single scale with 0 indicating no symptoms and higher scores indicating mild, moderate, and severe symptoms. Time to improvement of individual influenza symptoms are defined as the time from the start of treatment to the time when each of the influenza symptoms are alleviated, maintained, or improved for a duration of at least 21.5 hours. These are defined as: pre-existing symptoms (cough, fatigue, or muscle/join pain that existed prior to influenza) that were worse at baseline and had improved at least 1 point from baseline; pre-existing symptoms not worse at baseline that maintained baseline severity; and new symptoms that were alleviated, defined as a symptom score of non (0) or mild (1).

Outcome measures

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=1 Participants Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Time to Improvement of Individual Influenza Symptoms as Assessed by Patient-reported Outcome Measures on a Single Scale	—	8 Days to recovery

SECONDARY outcome

Timeframe: Day 1 to Day 30

Population: The only patient that completed the study, was randomized into the placebo arm.

A composite score of multiple measures will be used and calculated by count of patients who experience each influenza-related complications. Adverse events will only include those that are determined to be related to the study drug.

Outcome measures

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=1 Participants Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Percentage of Patients Who Experience Each Influenza-related Complications: Hospitalization, Death, Sinusitis, Otitis Media, Bronchitis, and Radiologically-confirmed Pneumonia as an Adverse Event After the Initiation of Study Treatment	—	0 Number of patients with complications.

SECONDARY outcome

Timeframe: Day 1 to Day 30

Population: The only patient that completed the study, was randomized into the placebo arm.

Preinfluenza health status will be measured on a score from 0 (worst possible health) to 10 (normal health [for someone your age and condition]).

Outcome measures

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=1 Participants Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Time to Return to Preinfluenza Health Status	—	8 Days

SECONDARY outcome

Timeframe: Baseline to Day 30

Population: The only patient that completed the study, was randomized into the placebo arm.

Time to viral clearance will be assessed by percentage of participants positive by influenza plaque assay at each time-point.

Outcome measures

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=1 Participants Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Time to Viral Clearance, as Assessed by Difference in Percentage of Participants Positive by Influenza Plaque Assay at Each Time-point (in Each Treatment Group)	—	8 Days

SECONDARY outcome

Timeframe: Baseline to Day 30

Population: The only patient that completed the study, was randomized into the placebo arm.

Time to viral clearance will be assessed by percentage of participants positive by qPCR at each time-point.

Outcome measures

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=1 Participants Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Time to Viral Clearance, as Assessed by Difference in Percentage of Participants Positive by Quantitative Real Time Polymerase Chain Reaction	—	8 Days

SECONDARY outcome

Timeframe: Baseline to Day 30

Population: The only patient that completed the study, was randomized into the placebo arm.

Treatment-emergent variants will be identified using direct next-generation sequencing of a comprehensive panel of genes.

Outcome measures

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=1 Participants Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Change of Treatment-emergent Variants of Neuraminidase and Polymerase Known to Confer Antiviral Resistance to Oseltamivir in Each Arm by Direct Next-generation Sequencing Symptoms	—	0 Resistant variant

SECONDARY outcome

Timeframe: Day 1 to Day 15

Population: The only patient that completed the study, was randomized into the placebo arm.

Adverse events will only include those that are determined to be related to the study drug and will assess the safety and tolerability of Baloxavir in Combination with SOC treatment.

Outcome measures

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=1 Participants Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Percentage of Participants With Adverse Events (AEs)	—	1 Participants

Adverse Events

Active and Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo and Standard of Care

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=2 participants at risk Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Renal and urinary disorders renal insufficiency	— 0/0 • 1 month 0 Participants were analyzed in the Active and Standard of Care arm because 0 subjects were enrolled in that arm.	50.0% 1/2 • Number of events 1 • 1 month 0 Participants were analyzed in the Active and Standard of Care arm because 0 subjects were enrolled in that arm.

Other adverse events

Measure	Active and Standard of Care Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.	Placebo and Standard of Care n=2 participants at risk Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days.
Skin and subcutaneous tissue disorders alopecia	— 0/0 • 1 month 0 Participants were analyzed in the Active and Standard of Care arm because 0 subjects were enrolled in that arm.	50.0% 1/2 • Number of events 1 • 1 month 0 Participants were analyzed in the Active and Standard of Care arm because 0 subjects were enrolled in that arm.

Additional Information

Dr. Mirella Salvatore

Weill Cornell Medicine

Phone: (646) 318-8506

Email: mis2053@med.cornell.edu

Results disclosure agreements

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