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Table 5 Summary of AEs

From: Pharmacokinetic comparability of Prolastin®-C to Prolastin® in alpha1-antitrypsin deficiency: a randomized study

 

Double-blind Crossover Phase

Open-label Phase

 

Prolastin-C (n = 24)

8 Weeks

Prolastin (n = 24)

8 Weeks

Prolastin-C (n = 24)

8 Weeks

AEs by subject

   

Any AE, n (%)

11 (45.8)

9 (37.5)

11 (45.8)

AEs by total number and rate per infusion

   

Total number of AEs (rate per infusion)

22 (0.117)

15 (0.078)

14 (0.073)

Total number of AEs occurring in ≥ 2 subjects (rate per infusion)

   

   Upper respiratory tract infection

2 (0.011)

1 (0.005)

1 (0.005)

   Urinary tract infection

1 (0.005)

0

2 (0.010)

   Headache

1 (0.005)

2 (0.010)

0

   Rales

0

0

2 (0.010)

   Arthralgia

0

2 (0.010)

0

AEs leading to withdrawal

0

0

0

Total number of SAEs (rate per infusion)

0

2 (0.010)

0

Deaths

0

0

0

  1. Total number of weekly infusions: Prolastin-C, 380 (double-blind plus open-label phases); 188 (double-blind phase only); 192 (open-label phase only). Prolastin, 192 (double-blind phase only).