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Table E-5Quality assessment of studies reporting harms of adjuvant therapies for PKU

Author, YearHarms predefined using standardized/precise definitionsSerious events precisely definedSevere events precisely definedDeaths/group specifiedActive harms collectionPassive harms collectionSpecified who collected harmsTraining/background of individuals(s) collecting harms specifiedTiming of harms collection specifiedStandard scale for harms collection usedSpecified whether reported harms encompass all events collectedNumber participants withdrawing/lost to followup reported by groupTotal number participants affected by harms specified by groupNumber for each type of harm specified by groupAnalyses for harms data specified
BH4
Humphrey 201113
Burton 201114-+++++--+-+++++
Burton 201010-----------NA---
Vernon 20106-----------+---
Burlina 200911-----------NA---
Trefz 20091-U--+++++-+++++
Lee 20087++++++++++++++U
Levy 20072-----------NA---
Lambruschini 200512----UU+---NA+NANANA
LNAAs
Schindeler 20073-----+---U-NA---
Matalon 20074-----------NA---
Matalon 20068-----------NA---

+= yes/positive; -=no/negative; LNAA=large neutral amino acids; NA=not applicable; U=unsure

From: Appendix E, Quality of the Literature

Cover of Adjuvant Treatment for Phenylketonuria (PKU)
Adjuvant Treatment for Phenylketonuria (PKU) [Internet].
Comparative Effectiveness Reviews, No. 56.
Lindegren ML, Krishnaswami S, Fonnesbeck C, et al.

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