Table 5 The relationship between an adverse event and the intervention
Type of adverse events and relationship to the intervention | Description |
|---|---|
Unrelated | • No temporal association to study intervention |
• An alternative aetiology has been established | |
• The event does not follow the known pattern of response to study intervention | |
• The event does not reappear or worsen with re-challenge | |
Unlikely to be related | • No temporal association to study intervention |
• Event could readily be produced by clinical state, environmental or other interventions | |
• The event does not follow the known pattern of response to study intervention | |
• The event does not reappear or worsen with re-challenge | |
Possibly related | • Reasonable temporal relationship to study intervention |
• The event is not readily produced by clinical state, environmental, or other interventions | |
• The event follows a known pattern of response to the study intervention or as yet unknown pattern of response | |
Definitely related | • There is a reasonable temporal relationship to the study intervention |
• The event is not readily produced by clinical state, environmental, or other interventions | |
• The event follows a known pattern of response to the study intervention | |
• The event decreases with de-challenge and recurs with re-challenge | |
Unassessable | • Anything that does not fall into the above categories |