Table 2.

Adverse Events and Upper-Level Events by Treatment Group

Body System	No. of Adverse Events in Patients Receiving Amitriptyline Plus		No. of Upper-Level Events in Patients Receiving Amitriptyline Plusa
	Cognitive Behavioral Therapy (n = 64)	Headache Education (n =71)	Cognitive Behavioral Therapy (n = 64)	Headache Education (n = 71)
Head, eye, ear, nose, and throat	30	25	0	1
Central nervous systemb	13c	28c	1	4
Gastrointestinal	10	11	0	0
Musculoskeletal	6	9	0	0
Cardiovascular	8	6	2	2
Behavioral	6	6	3	6
Dermatological	4	6	0	1
Respiratoryb	1c	8c	0	0
Hematopoietic or lymphatic	5	4	1	1
Genitourinary	4	4	0	0
Other	2	1	0	1
Endocrine or metabolic	1	1	0	0
Total events	90	109	7	16

^aUpper level events defined by either intensity at level 3 or above (severe or life threatening), relationship at level 4 or above (probable or definite), and action at level 4 or above (medication discontinued or dose reduction).

^bThe majority of central nervous system adverse events involved status migranosus or worsening of migraine, and others included expected adverse effects of amitriptyline (fatigue or drowsiness and dizziness). Respiratory adverse events included expected events for youth, including influenza, pneumonia, seasonal allergies, asthma exacerbations, and upper respiratory infections.

^cEach of these group comparisons yielded a P value of .02; however, use of the χ² test for respiratory events may not be valid because expected cell frequencies are less than 5.