TABLE 1.

Examples of Difficulties in Adverse Event Labeling^a

Original Label	Original Investigator Text From Adverse Event Report
Personality disorder	[A] 10-year-old male exhibited symptoms of personality disorder of moderate severity and was discontinued. One day later, [the patient] attempted to hang himself with a rope after [a] dispute with his father. [The] investigator did not consider this a serious adverse event but rather part of the personality disorder.
Accidental overdose and neurosis	The overdose of six capsules of study medication was in fact intentional and in response to an argument with the subject’s mother.
Medication error	Age 14: The patient took 11 tablets impulsively and then went to school…the patient denied that it was a suicide attempt.
Suicide attempt Hostility	[The patient] had thoughts of killing self but had no intention of acting on them. Age 10: Before his mother’s call to the site and again after arguing with his stepfather, he wrapped a cord from the miniblinds around his neck, threatening to kill himself.
Emotional lability/suicide attempt	Age 14: The patient is reported to have engaged in an episode of “automutilation,” where she slapped herself in the face.

^aThese labels were given by the study clinicians in the pharmaceutical company trials. They were given prior to the implementation of C-CASA and reflect why reclassification was necessary. Some labels are more severe than they should be, and other labels are less severe than warranted.