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Table 2 Summary of adverse events

From: Amyloid positron emission tomography and cerebrospinal fluid results from a crenezumab anti-amyloid-beta antibody double-blind, placebo-controlled, randomized phase II study in mild-to-moderate Alzheimer’s disease (BLAZE)

 

Low-dose SC cohort (n = 39)

High-dose IV cohort (n = 52)

All patients (n = 91)

Placebo (n = 13)

Crenezumab (n = 26)

Placebo (n = 16)

Crenezumab (n = 36)

Placebo (n = 29)

Crenezumab (n = 62)

Patients with ≥ 1 AE

13 (100)

26 (100)

15 (93.8)

32 (88.9)

28 (96.6)

58 (93.5)

Death

0 (0.0)

0 (0.0)

0 (0.0)

2 (5.6)*

0 (0.0)

2 (3.2)*

SAEs

1 (7.7)

3 (11.5)

3 (18.8)

6 (16.7)

4 (13.8)

9 (14.5)

AEs of grade ≥ 3

1 (7.7)

4 (15.4)

4 (25.0)

7 (19.4)

5 (17.2)

11 (17.7)

Pneumonia

0 (0.0)

1 (3.8)

0 (0.0)

1 (2.8)

0 (0.0)

2 (3.2)

Most frequent AEs

 Back pain

2 (15.4)

5 (19.2)

2 (12.5)

5 (13.9)

4 (13.8)

10 (16.1)

 Upper respiratory tract infection

0 (0.0)

7 (26.9)

2 (12.5)

4 (11.1)

2 (6.9)

11 (17.7)

 Anxiety

0 (0.0)

9 (34.6)

0 (0.0)

3 (8.3)

0 (0.0)

12 (19.4)

 Nasopharyngitis

4 (30.8)

4 (15.4)

13 (18.8)

1 (2.8)

7 (24.1)

5 (8.1)

 Depression

2 (15.4)

5 (19.2)

2 (12.5)

2 (5.6)

4 (13.8)

7 (11.3)

  1. Further details can be found in the Additional file 1 (Supplementary safety summary)
  2. All values are shown as n (%)
  3. AE adverse event, IV intravenous, SAE serious adverse event; SC subcutaneous
  4. *Neither fatal event was assessed as related to study drug by the investigator