Lee 2014.

Methods	A cohort study of medication‐related adverse events in children and adolescents reported to the US Food and Drugs Administration (FDA) from 2007 to 2012
Participants	Number of patients screened: not stated Number of participants included: 4055 Diagnosis of ADHD: not stated Age: mean 10.2 years (range: 1‐17) IQ: not stated Sex: not stated Ethnicity: not stated Country: USA Comorbidity: not stated Comedication: not stated Sociodemographics: not stated Inclusion criteria: All patient reports submitted to the FDA Adverse Event Reporting System (FAERS) between 1 January 2007 and 27 August 2012 for children (1‐11 years) and adolescents (12‐17 yrs) Exclusion criteria: none stated
Interventions	Methylphenidate type: not stated Mean methylphenidate dosage: not stated Administration schedule: not stated Duration of intervention: not stated Treatment compliance: not stated
Outcomes	Type of adverse event: all adverse events and adverse events with serious outcomes. The description of the adverse events is coded based on a 'preferred term' from the Medical Dictionary for Regulatory Activities (MedDRA) terminology
Notes	Sample calculation: no Ethics approval: not reported Funding/vested interests/authors' affiliations: no Key conclusions of the study authors: our findings highlight the high‐risk medications and the corresponding adverse events commonly reported in children and adolescents. Information from this analysis can be used to prioritise drugs and adverse events that might be investigated in future studies of drug safety in children Comments from the study authors: our findings are consistent with other studies that have used data from spontaneous reporting systems to examine the adverse events in children Supplemental information regarding data and IQ requested through personal email correspondence with the authors in June 2016 (Schumock 2016 [pers comm]). The authors were not able to retrieve the information