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Table 4 Prespecified definitions for clinical endpoints

From: Feasibility of randomizing Danish citizens aged 65–79 years to high-dose quadrivalent influenza vaccine vs. standard-dose quadrivalent influenza vaccine in a pragmatic registry-based setting: rationale and design of the DANFLU-1 Trial

Endpoint

ICD-10 codes

Diagnosis type

Inpatient/outpatient/minimum required length of stay/other criteria

Timeframe

Influenza and/or pneumonia hospitalization

J09-J18

A

Inpatient, at least 1 night

≥ 14 days after vaccination and up to May 31, 2022

Respiratory disease hospitalization

J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85-J86, J96

A

Inpatient, at least 1 night

≥ 14 days after vaccination and up to May 31, 2022

Cardiovascular disease hospitalization

I11, I13, I20-I25, I30-I31, I33, I38-I42, I46-I50, I60-I69, I74

A

Inpatient, at least 1 night

≥ 14 days after vaccination and up to May 31, 2022

Cardio-respiratory disease hospitalization

I11, I13, I20-I25, I30-I31, I33, I38-I42, I46-I50, I60-I69, I74, J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85-J86, J96

A

Inpatient, at least 1 night

≥ 14 days after vaccination and up to May 31, 2022

Any hospitalization

Any

Any

Inpatient, at least 1 night

≥ 14 days after vaccination and up to May 31, 2022

COVID-19 hospitalization

B342, B972

A

Inpatient, at least 1 night

≥ 14 days after vaccination and up to May 31, 2022

All-cause death

≥ 14 days after vaccination and up to May 31, 2022

  1. All clinical endpoints are defined from ICD-10 codes. ICD International Classification of Diseases