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Drug Trial Snapshot: EMPAVELI

What are the possible side effects (results of trials used to assess safety)?

The table below summarizes adverse reactions in the Trial APL2-302.

Treatment-Emergent Adverse Events Reported in ≥ 5% of Patients Treated With EMPAVELI

Adverse Reaction

EMPAVELI
(N=41)
n (%)

Eculizumab
(N=39)
n (%)

General disorders and administration site conditions

     Injection site reaction*

     Fatigue*

     Chest pain*

 

16 (39)

5 (12)

3 (7)

 

2 (5.1)

9 (23.1)

1 (2.6)

Infections*

     Respiratory tract infection*

     Viral infection

12 (29)

6 (15)

5 (12)

10 (25.6)

5 (12.8)

3 (7.7)

Gastrointestinal disorders

     Diarrhea

     Abdominal pain*

 

9 (22)

8 (20)

 

1 (2.6)

4 (10.3)

Nervous system disorders

     Headache

 

3 (7)

 

9 (23)

Musculoskeletal disorders

     Back pain*

 

3 (7)

 

4 (10)

Cardiovascular disorders

     Systemic hypertension*

 

3 (7)

 

1 (3)

*The following terms were combined:
Abdominal pain includes: abdominal pain upper, abdominal discomfort, abdominal pain, abdominal pain lower, abdominal tenderness, epigastric discomfort
Back pain includes: back pain, sciatica
Chest pain includes: chest discomfort, non-cardiac chest pain, musculoskeletal chest pain, chest pain
Fatigue includes: asthenia, lethargy, fatigue
Infections include: oral herpes, bacterial infection, fungal infection, gastrointestinal infection, gastrointestinal viral infection, influenza-like illness, nasopharyngitis, pulpitis dental, rhinitis, tonsillitis, tonsillitis bacterial, vulvovaginal mycotic infection, hordeolum, sepsis, furuncle, otitis externa, viral respiratory tract infection, gastroenteritis, upper respiratory tract infection, bronchitis, ear infection, respiratory tract infection, rhinovirus infection, sinusitis, urinary tract infection
Injection-site reaction includes: injection-site erythema, injection-site reaction, injection-site swelling, injection-site induration, injection-site bruising, injection-site pain, injection-site pruritus, vaccination-site reaction, administration-site swelling, injection-site hemorrhage, injection-site edema, injection-site warmth, administration-site pain, application-site pain, injection-site mass, injection-site rash, vaccination-site pain
Respiratory tract infection includes: influenza-like illness, nasopharyngitis, rhinitis, tonsillitis, viral upper respiratory tract infection, upper respiratory tract infection, respiratory tract infection, sinusitis
Systemic hypertension includes: hypertension
Viral infection includes: oral herpes, gastrointestinal viral infection, viral upper respiratory tract infection, rhinovirus

EMPAVELI may cause serious infections caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y, and B, and Haemophilus influenza type B.

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