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. Author manuscript; available in PMC: 2023 May 1.
Published in final edited form as: J Am Acad Child Adolesc Psychiatry. 2021 Jul 22;61(5):647–661. doi: 10.1016/j.jaac.2021.07.005

Table 4:

Treatment-Emergent Adverse Eventsa Based on the Pediatric Adverse Events Rating Scale

Adverse event question Micronutrient
N (%)
Placebo
N (%)
Total
N (%)
Irritability 1 (1.6) 1 (3.0) 2 (2.1)
Angry or hostile 3 (4.7) 1 (3.0) 4 (4.1)
Sad or low mood 2 (3.1) 0 (0.0) 2 (2.1)
Lack of interest 2 (3.1) 0 (0.0) 2 (2.1)
Mood swings 2 (3.1) 1 (3.0) 3 (3.1)
Anxious, tense or uptight 3 (4.7) 1 (3.0) 4 (4.1)
Lack of self-control/impulsive 3 (4.7) 2 (6.1) 5 (5.2)
Trouble paying attention or concentrating 2 (3.1) 0 (0.0) 2 (2.1)
Racing thoughts 1 (1.6) 1 (3.0) 2 (2.1)
Can't sit or stand still 3 (4.7) 1 (3.0) 4 (4.1)
Tired/fatigued 2 (3.1) 1 (3.0) 3 (3.1)
Trouble falling asleep 4 (6.3) 1 (3.0) 5 (5.2)
Tried to hurt him/herself 1 (1.6) 0 (0.0) 1 (1.0)
Hurt someone or something 1 (1.6) 1 (3.0) 2 (2.1)
Less hungry 4 (6.3) 1 (3.0) 5 (5.2)
Lost weight 0 (0.0) 1 (3.0) 1 (1.0)
Dry mouth 1 (1.6) 0 (0.0) 1 (1.0)
Gained weight 0 (0.0) 1 (3.0) 1 (1.0)
Muscle shaking, stiffness or cramps 0 (0.0) 1 (3.0) 1 (1.0)
Tics 0 (0.0) 1 (3.0) 1 (1.0)
Unusually good mood or super happy 1 (1.6) 1 (3.0) 2 (2.1)
Skin rash or irritation 1 (1.6) 0 (0.0) 1 (1.0)
Heart racing or skipping beats 0 (0.0) 1 (3.0) 1 (1.0)
GI Symptomsb 17 (26.6)c 8 (24.2)c 25 (25.8)
 Stomach ache or cramps 7 (10.9) 6 (18.2) 13 (13.4)
 Nausea/sick to stomach 3 (4.7) 1 (3.0) 4 (4.1)
 Throwing up/vomiting 4 (6.3) 0 (0.0) 4 (4.1)
 Diarrhea 7 (10.9) 1 (3.0) 8 (8.2)
Headache 1 (1.6) 2 (6.1) 3 (3.1)
Other 5 (7.8) 5 (15.2) 10 (10.3)

Note:

a

AEs rated as “possibly,” “probably,” or “likely” attributable to the intervention. Number and percentages refer to participants having the AE, not number of AEs

b

GI = Gastrointestinal; symptoms are a combination of discrete participants experiencing stomach ache or cramps, nausea/sick to stomach, throwing up/vomiting, and diarrhea

c

p = 0.80