Table 5.
ROR025 of suspected SAGE-related PTs
| Gadopentetate dimeglumine | Gadobenate dimeglumine | Gadoxetate disodium | Gadoterate meglumine | Gadodiamide | Gadoversetamide | Gadoteridol | Gadobutrol | |
|---|---|---|---|---|---|---|---|---|
| Skin and subcutaneous tissue disorders | ||||||||
| Pain of skin | 10.904 | 14.933 | / | 2.518 | 29.934 | 49.283 | 28.921 | / |
| Skin burning sensation | 2.628 | 3.766 | / | 4.539 | 2.668 | 5.396 | 2.247 | 4.471 |
| Skin discoloration | / | / | / | 2.074 | 10.778 | 17.82 | 13.686 | 2.045 |
| Skin induration | 235.878 | 195.828 | / | / | 488.827 | 655.195 | 400.833 | 7.906 |
| Skin tightness | / | / | / | 18.855 | 233.292 | / | 271.484 | 6.609 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 1.12 | 1.093 | / | / | 2.31 | 2.19 | 1.049 | / |
| Bone pain | / | / | / | 4.21 | 3.953 | 6.304 | 3.016 | 2.177 |
| Joint stiffness | / | / | / | / | / | 40.735 | 24.8 | / |
| Muscle fatigue | / | / | / | / | / | 1.169 | / | / |
| Muscle tightness | 7.548 | 4.041 | / | 1.867 | 7.371 | 13.167 | 10.56 | 2.819 |
| Muscle twitching | / | / | 6.986 | / | / | / | 5.372 | |
| Muscular weakness | 2.138 | 2.069 | / | 1.602 | 4.929 | 6.085 | 4.456 | / |
| Musculoskeletal chest pain | / | 1.903 | / | / | / | / | / | / |
| Pain in extremity | 2.057 | 1.268 | / | / | 2.823 | 2.455 | 1.884 | / |
| General disorders and administration site conditions | ||||||||
| Asthenia | / | / | / | / | 1.195 | 1.319 | 1.175 | / |
| Pain | 4.519 | 6.109 | / | / | 11.639 | 37.736 | 18.065 | / |
| Nervous system disorders | ||||||||
| Cognitive disorder | / | 1.215 | / | 1.757 | 1.471 | 2.588 | / | 2.283 |
| Headache | / | / | / | 2.154 | / | / | / | 1.112 |
| Paraesthesia | 1.932 | 2.201 | / | 6.937 | 1.367 | / | / | 2.502 |
| Neuralgia | / | / | / | 1.415 | / | / | / | / |
| Investigations | ||||||||
| Quality of life decreased | 9.895 | 6.255 | / | / | 17.876 | 38.002 | 16.395 | 1.739 |
| Number of signals at PT level | 10 | 12 | 0 | 12 | 15 | 15 | 14 | 11 |
ROR reporting odds ratio, SAGE symptoms associated with gadolinium exposure, PTs preferred terms