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Table 6 Assigning Type of AE/AR through causality

From: Empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia: study protocol for a multicenter, open-label randomized controlled clinical trial

Relationship

Description

AE type

Unrelated

There is no evidence of any causal relationship.

Unrelated AE

Unlikely

There is little evidence to suggest that there is a causal relationship (for example, the event did not occur within a reasonable time after the administration of the trial medication). There is another reasonable explanation for the event (for example, the patient’s clinical condition, and other concomitant treatment).

Unrelated AE

Possible

There is some evidence to suggest a causal relationship (for example, because the event occurs within a reasonable time after administration of the trial medication). However, the influence of other factors may have contributed to the event (for example, the patient’s clinical condition, and other concomitant treatments).

AR

Probable

There is evidence to suggest a causal relationship and the influence of other factors is unlikely.

AR

Definitely

There is clear evidence to suggest a causal relationship and other possible contributing factors can be ruled out.

AR