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Table 3 Summary of TEAEs

From: Safety and efficacy of first-in-man intrathecal injection of human astrocytes (AstroRx®) in ALS patients: phase I/IIa clinical trial results

Category

A

B

A + B

(N = 5)

(N = 5)

(N = 10)

Patients n (%)

Events n

Patients n (%)

Events n

Patients n (%)

Events n

Any TEAE

5 (100)

54

5 (100)

32

10 (100)

86

Death

1 (20)

 

2 (40)

 

3 (30)

 

Any Serious TEAE

2 (40)

5

4 (40)

4

6 (60)

9

Any Severe TEAE

1 (20)

2

2 (40)

2

3 (10)

4

Any TEAE related to the study drug AstroRx®

0

0

0

0

0

0

Any TEAE related to IT Procedure

3 (60)

6

4 (80)

6

7 (70)

12

Any TEAE related to immunosuppression

1 (20)

2

2 (40)

2

3 (30)

4

TEAEs Severity

 Mild

5 (100)

41

5 (100)

22

10 (100)

63

 Moderate

4 (80)

11

4 (80)

8

8 (80)

19

 Severe

1 (20)

2

2 (40)

2

3 (10)

4