APPENDICES. A systematic review and economic model of the ...

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Appendix 12
Core symptoms Educational performance Quality of life Adverse events
Not reported Not reported Adverse events occurring in >2% of patients: ITT population (results not
reported by dose)
MCD CON Placebo
(n = 174) (n = 181) (n = 183)
Gastrointestinal disorders 8 (4.6%) 11 (6.1%) 13 (7.1%)
Abdominal pain upper 6 (3.4%) 8 (4.4%) 6 (3.3%)
Vomiting 1 (0.6%) 1 (0.6%) 4 (2.2%)
Infections and infestations 1 (0.6%) 5 (2.8%) 2 (1.1%)
Injury, poisoning and procedural 6 (3.4%) 3 (1.7%) 5 (2.7%)
complications
Metabolism and nutrition disorders 8 (4.6%) 11 (6.1%) 4 (2.2%)
Anorexia 5 (2.9%) 5 (2.8%) 2 (1.1%)
Appetite decreased 3 (1.7%) 6 (3.3%) 1 (0.5%)
Nervous system disorders 6 (3.4%) 10 (5.5%) 10 (5.5%)
Headache 3 (1.7%) 7 (3.9%) 6 (3.3%)
Psychiatric disorders 12 (6.9%) 13 (7.2%) 17 (9.3%)
Insomnia 3 (1.7%) 3 (1.7%) 6 (3.3%)
Irritability 3 (1.7%) 2 (1.1%) 5 (2.7%)
SKAMP: deportment
MCD vs CON: mean difference = 1.62,
p < 0.001; MCD > CON
SKAMP: attention
MCD vs CON: mean difference = 0.86,
p = 0.0003; CON > MCD
MCD and CON vs placebo not
reported. Results not reported by dose
Conclusions Authors’ conclusions: The authors state that once-daily doses of MCD and CON produced statistically significantly different
pharmacodynamic effects on surrogate measures of behaviour and performance among children with ADHD in the laboratory school
setting
Reviewer’s comments: No comments noted