-<ClinicalUseIssue xmlns="http://hl7.org/fhir">
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1437"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Oropharnygealpain"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Gastrointestinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Verycommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseIssue>