Table 2

Symptoms assessed across PROs in CD

SymptomCDSD112CD-PRO27CSI31CDAQ121GSRS117CD-GSRS148
Abdominal painXXXXXX
DiarrhoeaXXXX†XX
BloatingXXXXXX
NauseaXXXXXX
ConstipationXX†X
Fatigue*XXXX
Headache*XXX
Skin rashX
FlatulenceXXXX
BurpingXX
Problems thinking*XX
Incomplete emptyingXX
Loss of appetiteX
Hunger painsXXX
Stomach rumblingXXXX
RefluxX
  • *Removed from final PRO as per the Food and Drug Administration recommendations.

  • †Assessed in a single domain.

  • CD, coeliac disease; CDAQ, Celiac Disease Assessment Questionnaire; CDSD, Celiac Disease Symptom Diary; CSI, Celiac Symptom Index; GSRS, Gastrointestinal Symptom Rating Scale; PRO, patient-reported outcome.