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Table 8 Serious infectious adverse events reported in blinded and open-label trials and real world evidence

From: Increased infection risk in patients on preventive CGRP-targeting therapies– a meta-analysis and clinical effect assessment

 

Gastrointestinal

Respiratory

Genitourinary

Skin & connective tissue

Sepsis

Other & unclassified

Erenumab

NCT03096834

1

1

1

1

  

NCT01952574

3

1

1

1

  

NCT02456740

3

 

1

1

 

1

NCT02630459

4

3

    

NCT03812224

 

1

    

NCT02483585

1

1

  

1

1

NCT03333109

1

     

NCT03867201

     

1

NCT03971071

1

     

NCT02174861

1

1

    

BASEC ID 2018–02375

2

1

    

Fremanezumab

NCT03308968

1

     

NCT02021773

 

1

    

NCT02621931

 

1

    

Galcanezumab

NCT03559257

 

2

    

NCT02614196

 

1

    

NCT02438826

4

     

NCT03963232

1

 

1

1

  

NCT02614261

1

1

2

1

 

1

NCT02959190

 

1

    

Eptinezumab

NCT04418765

5

5

1

1

3

 

NCT01772524

  

1

   

NCT02275117

1

 

1

   

NCT02974153

1

     

Rimegepant

NCT03266588

2

2

 

1

 

1

NCT03732638

1

     

Atogepant

NCT03855137

1

2

    

NCT03700320

 

2

  

1

1

NCT03939312

2

1

   

1

NCT02848326

1

     
 

36

29

10

7

5

7

  1. Gastrointestinal SAEs: gastroenterocolitis, gastrointestinal tuberculosis, herpes simplex hepatitis, diverticulitis, abdominal abscess, tooth abscess, rectal abscess, peritonitis, anal abscess, Clostridium difficile colitis; respiratory SAEs: pneumonia, mycoplasma infection, pharyngitis, tonsillitis, COVID-19, influenza; genitourinary SAEs: urinary tract infection, pyelonephritis, tubo-ovarian abscess, vaginal abscess; Skin and connective tissue SAEs: cellulitis, erysipelas, infected dermal cyst, pilonidal disease; Sepsis included 1 case of bacteraemia; other and unclassified SAEs: beta-haemolytic streptococcal infection, staphylococcal infection, pericarditis, meningitis, osteomyelitis, mastitis