Centrophenoxine - Table 5 - Risks
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 |