Centrophenoxine - Table 5 - Risks



Category

Risk

Severity/Intolerability

Frequency

Detectability

Mitigation

Sum 

Weight

Score

Uncertainty

Weighted Score

Category

Risk

Severity/Intolerability

Frequency

Detectability

Mitigation

Sum 

Weight

Score

Uncertainty

Weighted Score

1

CNS

↓ recovery after cerebral infarction

2

1

2

2

7

1.75

-1

1 RCT: Cooperation Study Group on Acute Cerebrovascular Diseases, 1978

-0.75

2

CNS

↑ neurological AEs

1

2

1

1

5

1.25

-1

1 RCT: Itoh et al., 1968

2 Open-label: Fu et al., 2007

-1

3

CNS

↑ Parkinsonism

2

2

2

2

8

2

-1

2 Open-label: Izumi et al., 1986

-0.5

4

CNS

↑ jitteriness/agitation

1

3

2

1

7

1.75

-1

2 Open-label: Schmid & Schlick, 1979

-0.5

5

CNS

↑ insomnia

1

1

1

1

4

1

-1

1 RCT: Itoh et al., 1968

2 Open-label: Zhang & Wang, 2007

0

6

CNS

↑ epileptic seizures

2

2

2

2

8

2

-1

2 Comparative: Wasilewski et al., 1981

-1

7

CNS

↓ general cognition in older adults

1

2

2

2

7

1.75

-1

1 RCT: Pék et al., 1989

-1.75

8

CNS

↓ mental performance/learning in children

2

1

 

2

2

7

1.75

-1

1 RCT: Teichmann & Schwebke, 1973

-1.75

9

Gastrointestinal

↑ nausea

1

1

1

1

4

1

-1

1 RCT: Itoh et al., 1968

2 Open-label: Fu et al., 2007; Zhang & Wang, 2007

0

10

Gastrointestinal

↑ gastric pain

1

2

1

1

5

1.25

-1

2 Open-label: Schmid & Schlick, 1979

0

11

General

↑ unspecified AEs

1

1

1

1

4

1

-1

1 RCT: Lin, 2014; Hasegawa et al., 1976

2 Comparative: Ma et al., 2020

-1

12

General

mortality in elderly

3

2

3

2

10

2.5

-1

1 RCT: Pék et al., 1989; Robinson, 1978

-1.75

13

Hepatic

↑ ALT levels

1

1

2

2

6

1.5

-1

2 Comparative: Hu et al., 2008

-0.75

14

Immune

allergic reaction

1

1

1

2

5

1.25

-1

3 Observational: Chen & Wu, 2005

0

15

Psychiatric

↑ mood alterations in patients with neurological disorders

2

2

1

2

7

1.75

-1

2 Open-label: Ziolko, 1961

-1

16

Urinary

↑ BUN, creatinine and urination

1

1

1

2

5

1.25

-1

3 Observational: Chen & Zheng, 2010

0

17

Hypothetical risk

↑ G6PD & catalase inhibition

1

1

2

1

5

1.25

-1

3 Pre-clinical: Alicigüzel et al., 2001

0