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Tuesday

 

SATIVEX: An Observational Post-Marketing Safety Registry (Sativex is a medical marijuana spray)

Primary Outcome Measures:
Incidence rates of adverse events. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ] [ Designated as safety issue: Yes ]
The number of treatment-emergent adverse events was recorded. The incidence rate (number of patients divided by the total patient-years exposure to Sativex®) for each adverse event is presented.


Secondary Outcome Measures:
Average daily number of sprays of Sativex® used. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ] [ Designated as safety issue: Yes ]
The average daily dose of Sativex® was recorded and is presented.

Number of patients experiencing fall-related injuries requiring medical attention. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ] [ Designated as safety issue: Yes ]
Patients were asked if they had sought medical attention because of a fall-related injury; since they started taking Sativex® (initial record); during this period (follow-up records). The number of patients answering 'yes' is presented.

Number of patients experiencing a change in driving ability. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ] [ Designated as safety issue: Yes ]
Patients were asked to report any change in their driving ability; since they started taking Sativex® (initial record); during this period (follow-up records). The markers were: Improved, No change, Deteriorated, Not appropriate. The number of patients for each marker is presented.

Number of patients experiencing suicidal thoughts or attempts. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ] [ Designated as safety issue: Yes ]
Patients were asked if they had experienced any suicidal thoughts or attempted suicide; since they started taking Sativex® (initial record); during this period (follow-up records). The number of patients answering 'yes' is presented.

Number of patients experiencing significant psychiatric or psychotic events other than suicidality. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ] [ Designated as safety issue: Yes ]
Patients were asked if they had experienced any significant psychiatric or psychotic events other than suicidality; since they started taking Sativex® (initial record); during this period (follow-up records). The number of patients answering 'yes' is presented.

Incidence of patient deaths. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ] [ Designated as safety issue: Yes ]
The incidence of treatment-emergent deaths was recorded and the number of patient deaths is presented.

Number of patients receiving worthwhile benefit from Sativex®. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ] [ Designated as safety issue: No ]
Patients were asked if Sativex® was providing worthwhile benefit. The number of patients answering 'yes' at one or more time points is presented.

Number of MS patients discontinuing anti-spasticity medications. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ] [ Designated as safety issue: No ]
MS patients were asked what other anti-spasticity medications that have previously been used are now stopped permanently; since they started taking Sativex® (initial record); during this period (follow-up records). The number of patients for each discontinued medication is presented.

Number of MS patients discontinuing medications for MS symptoms other than anti-spasticity medications. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ] [ Designated as safety issue: No ]
MS patients were asked what medications for MS symptom other than anti-spasticity medications that have previously been used are now stopped permanently; since they started taking Sativex® (initial record); during this period (follow-up records). The number of patients for each discontinued medication is presented.
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