|
| Frequency | Duration* and outcome | Drug discontinued | Relation to drug | |
| Serious adverse events |
|
|
|
| |
|
| Death | 5 |
|
| Unrelated in all cases |
|
| Lumbar vertebral fracture | 1 | Persistent incapacity | NO | Unrelated |
| Non-serious adverse events |
|
|
|
| |
|
| Gastrointestinal problems** | 4 | Transient with full recovery | YES | Related |
| Transient with full recovery | YES | Related | |||
| Transient with full recovery | YES | Related | |||
| Persistent with improvement | Transient discontinuation | Unrelated | |||
|
| Hallucinations | 4 | Transient with full recovery | Decrease of dose | Related |
| Persistent with improvement | Transient discontinuation | Unrelated | |||
| Persistent with improvement | Transient discontinuation | Unrelated | |||
| Persistent with no change | YES | Related | |||
|
| Worsening of tremor | 3 | Transient with full recovery | YES | Related |
| Persistent with no change | Decrease of dose | Related | |||
| Persistent with worsening | Transient discontinuation | Unrelated | |||
|
| Sleep problems | 2 | Transient with full recovery | NO | Unrelated |
| Unknown | NO | Unknown | |||
|
| Dizziness | 2 | Transient with full recovery | YES | Related |
| Persistent with improvement | YES | Related | |||
|
| Urinary problems*** | 2 | Transient with full recovery | YES | Related |
| Transient with full recovery | YES | Related | |||
|
| Excitement | 2 | Persistent with no change | YES | Related |
| persistent with worsening | Transient discontinuation | Unrelated | |||
|
| Facial edema | 1 | Transient with full recovery | YES | Related |
|
| Nightmares | 1 | Transient with full recovery | YES | Related |
|
| Neck pain | 1 | Transient with full recovery | YES | Unrelated |
|
| Headache | 1 | Persistent with no change | Decrease of dose | Related |
|
| Gait impairment and fall | 1 | Transient with full recovery | NO | Unrelated |
|
| Sensation of suboccipital tension | 1 | Transient with full recovery | YES | Related |
|
| Weakness | 1 | Persistent with improvement | YES | Unrelated |
|
| Nervousness and agressivity | 1 | Transient with full recovery | Transient discontinuation | Related |
|
| Confusion | 1 | Persistent with improvement | YES | Unrelated |
|
| Discontinuation of the drug by the patient | 1 | Persistent with no change | YES | Unrelated |
|
| Not specified | 2 | Persistent with improvement | Transient discontinuation | Related |
| Unknown | Unknown | Unknown | |||