Table 2 Patients with at least one TEAE by seriousness, relatedness, and severity.

From: Placental expanded mesenchymal-like cells (PLX-R18) for poor graft function after hematopoietic cell transplantation: A phase I study

 

PLX-R18

PLX-R18

PLX-R18

Overall

1 M cells/kg (Cohort 1)

2 M cells/kg (Cohort 2)

4 M cells/kg (Cohort 3)

 

N = 3

N = 6

N = 12

N = 21

 

n (%)

n (%)

n (%)

n (%)

Patients with any TEAEs [1]

3 (100.0)

6 (100.0)

12 (100.0)

21 (100.0)

Patients with any serious TEAEs

3 (100.0)

4 (66.7)

8 (66.7)

15 (71.4)

Patients with TEAEs with fatal outcome

0

2 (33.3)

2 (16.7)

4 (19.0)

Patients with TEAEs by relationship throughout the study [2]

 Related

3 (100.0)

2 (33.3)

11 (91.7)

16 (76.2)

 Not related

0

4 (66.7)

1 (8.3)

5 (23.8)

Patients with TEAEs by highest severity throughout the study [2]

 Mild – Grade 1

0

0

3 (25.0)

3 (14.3)

 Moderate – Grade 2

0

2 (33.3)

2 (16.7)

4 (19.0)

 Severe – Grade 3-5

3 (100.0)

4 (66.7)

7 (58.3)

14 (66.7)

  1. TEAE Treatment emergent adverse event.
  2. [1] All non-serious TEAEs and serious TEAEs were collected throughout the study; TEAEs include serious TEAEs; all deaths were collected throughout the study.
  3. [2] In case of multiple events, the highest severity or relationship was counted.