Microbicide Trials Network



ANALDo not report MedDRA preferred term, please report the verbatim term!Verbatim termMedDRA Preferred Term (PT)Anal abscessAnal abscessBowen's diseaseBowen's diseaseAnal bruisingContusionAnal dischargeRectal dischargeAnal edemaOedemaAnal erythemaErythemaAnal fissureAnal fissureAnal fistulaAnal fistulaAnal hemorrhoidsHaemorrhoidsAnal intraepithelial neoplasia 1 (biopsy)Anogenital dysplasiaAnal intraepithelial neoplasia 2 (biopsy)Anogenital dysplasiaAnal itchingAnal pruritusAnal leukoplakiaAnal leukoplakiaAnal massMassAnal painProctalgiaAnal mucosal abrasionAnal injuryanal pain caused by insertion of study productProcedural painAnal mucosal erosionAnal erosionAnal ulcerAnal ulcerAnal wartsAnorectal Human Papillomavirus InfectionAnorectal pruritisAnal pruritusExternal anal condylomaAnorectal Human Papillomavirus InfectionExternal hemorrhoidHaemorrhoidsHemorrhoidHaemorrhoidsintermittent pain at site of perianal skinproctalgiaInternal anal condylomaAnorectal Human Papillomavirus Infectioninternal hemorrhoidHaemorrhoidsAnal Low grade squamous intraepithelial lesion (cytology)Anogenital dysplasiaperianal abscessAnal abscessPerianal dermatitisDermatitisPerianal dermatophyte infectionAnal fungal infectionPerianal ecchymosisAnal haemorrhagePerianal fistulaAnal fistulaPerianal fungal skin infectionAnal fungal infectionperianal irritationAnorectal discomfortPerianal itchAnal pruritusPerianal itchingAnal pruritusperianal painProctalgiaPerianal purpuraPurpuraperianal skin tearLacerationthrombosed hemorrhoidHaemorrhoidsAnal intraepithelial neoplasia 3 (biopsy)Anogenital dysplasiableeding internal hemorrhoidHaemorrhoidal haemorrhageAnal terms added to 20.1 for consideration:Anal candidiasisAnal dilationEczemaAnal erosionAnal hypoaesthesiaAnal incontinenceAnal inflammationAnal necrosisAnal paraesthesiaAnal polypAnal prolapseAnal spasmAnal palpillitisAnal tineaAnogenital wartsAnal skin tagAnal injuryAnal stenosisAnal trichiasis Anal ulcer haemorrhageAnorectal cellulitisAnorectal infectionAnorectal infection bacterialAnorectal stenosisAnorectal swellingAnorectal ulcerHaemorrhoids thrombosedAnorectal ulcerAnorectal varicesAnorectal varices haemorrhageAnorectal disorderCOLORECTALDo not report MedDRA preferred term, please report the verbatim term!Verbatim termMedDRA Preferred Term (PT)abdominal distensionAbdominal distensionbowel urgencyDefaecation urgencybowel urgency after study product useDefaecation urgencyChange in stool colorFaeces discolouredchange in stool consistencyAbnormal faecesclay colored stoolFaeces discoloureddiarrheaDiarrhoeadiarrhea - due to procedurePost procedural diarrhoeadull rectal painproctalgiaeffluent from enemaPost procedural drainageFecal incontinenceFaecal incontinencefecal urgencyDefaecation urgencyfecal urgency associated with diarrheaDiarrhoeaflatulenceFlatulenceflatulence after study gel useFlatulenceflatulence with bowel movementsFlatulenceincreased bowel movement frequencyFrequent bowel movementsincreased bowel movementsFrequent bowel movementsincreased gas/flatulenceFlatulenceloose stoolDiarrhoealoose stool - due to study product applicationPost procedural diarrhoealower abdominal bloating after study gel useAbdominal distensionmucositis - rectal erythemaproctitisnocturnal bowel movementsBowel movement irregularitysoft stoolsoft stoolspain during defecationPainful defecationpain, rectumproctalgiapainful defecationPainful defaecationproctalgiaProctalgiapurulent anal dischargeRectal dischargerectal dischargeRectal dischargerectal itchingPruritusrectal mucosa abrasionmucosal excoriationrectal mucosa bleedingRectal haemorrhagerectal mucosa erythemaErythemarectal polyprectal polyprectal tenesmusrectal tenesmusrectal ulcerationRectal ulcerrectal UrgencyDefaecation urgencyrectal urgency associated with diarrheaDiarrhoeastool consistency change (stickier and pasty)Abnormal faecesurgency to move bowelsDefaecation urgencyColorectal terms added to 20.1 for consideration:Rectal abscessColorectal cancerColorectal carcinomaRectal spasmRectal fissureRectal injuryRectal obstructionRectal neoplasmRectal perforationRectal prolapseRectal stenosisRectal tenesmusRectal ulcer haemorrhageSEXUALLY TRANSMITTED INFECTIONSDo not report MedDRA preferred term, please report the verbatim term!Verbatim termMedDRA Preferred Term (PT)anal syphilisSyphilis analanal HSVproctitus herpesperianal HSVgenital herpeslymphogranuloma venerumlymphogranuloma venereumlymphogranuloma venerum lymphadenitislymphogranuloma venereumlymphogranuloma venerum proctitislymphogranuloma venerumRectal ChlamydiaProctitis chlamydiaRectal GonorrheaProctitis gonococcalSyphilis (chancre)SyphilisSyphilis (condyloma lata)SyphilisOTHER GASTROINTESTINAL VERBATIM TERMSDo not report MedDRA preferred term, please report the verbatim term!Verbatim termMedDRA Preferred Term (PT)anorectal bleedingRectal hemorrhageaphthous ulcer in upper oral gutterAphthous stomatitisabdominal bloatingAbdominal distensionabdominal crampingAbdominal painabdominal crampsAbdominal painabdominal painAbdominal painacid refluxGastrooesophageal reflux diseasebad breathBreath odourBloatingAbdominal distensionbloating (related to sigmoidoscopy)Abdominal distensionblood in stool with frank red bloodHaematocheziaCramps - AbdominalAbdominal paindry throatDry throatfoul taste, throatDysgeusiagastroenteritisGastroenteritisGI bleedGastrointestinal haemorrhageHematocheziahaematochezialower abdominal painAbdominal pain lowermelenaMelaenanauseaNauseapilonidal cystPilonidal cystright sided lower abdominal painAbdominal pain lowerright upper quadrant painAbdominal pain upperStomach crampingAbdominal pain upperStomachacheAbdominal pain upperViral gastroenteritisGastroenteritis viralGastrointestinal necrosisPROBLEMATIC VERBATIM TERMSDo not report MedDRA preferred term, please report the verbatim term!Verbatim termMedDRA Preferred Term (COMMENTSAbdominal pain secondary to abdominal bloatingabdominal distensionThe reported term should be abdominal bloating. The pain should be listed as a sx of the bloating in the comments field.Anal carcinoma in situAnal cancer stage 0Clinically, "Anal intraepithelial neoplasia 3" and "Anal carcinoma in situ" are the same. However "anal carcinoma in situ" will map to "anal cancer stage 0" while "anal intraepithelial neoplasia 3" maps to "anogenital dysplasia". Preference would be to report as "anal intraepithelial neoplasia 3" if possible.Anal HSVProctitus herpesAnal HSV will map to "Proctitis herpes" and should be distinguished from "perianal herpes" which maps to "genital herpes". "Anal HSV" should only be reported if there is involvement of the anal or rectal mucosa.anal HSV ulcerProctitus herpesAnal ulcer HSV will map to "Proctitis herpes". Alternatively "perianal herpes" maps to "genital herpes".GasFlatulenceThe term gas will automatically map to a meddra preferred term of "flatulence". However, depending on symptoms reported by the participant "abdominal pain" or even "distension" may be more accurate.gas painFlatulenceThe term gas will automatically map to a meddra preferred term of "flatulence". However, depending on symptoms reported by the participant "abdominal pain" or even "distension" may be more accurate.Pain - abdomen & backnot codableThis would generate a query to separate the multiple anatomic locationsRectal friabilitynot codableNo term in MedDRA in Meddra exists for rectal friability. Currently, would ask clinican to query/code to Anorectal disorder.Anal skin tagAnal skin tagIf the site specifies "Anal Skin Tag" it will map to the preferred term of "Anal Skin Tag". If the site only reports skin tag, it will map to "acrochordon".study product residue,greasy anal residue sensationmedication residue present"Medication residue" can be captured, but "Residue sensation" can't be MedDRA coded - is the site trying to report that the ppt feels 'the sensation' of residue (similar to burning sensation, sensation of heaviness) or is residue is actually present? We only want one sx or dx per AE CRF.ASCUS (atypical cells of uncertain significance)not codableThis requires anatomical location. ASCUS is an exact match in the MedDRA dictionary to PT cervical dysplasia. Would generate queryPROBLEMATIC VERBATIM TERMSDo not report MedDRA preferred term, please report the verbatim term!Verbatim termMedDRA Preferred Term (COMMENTSepithelial disruptionnot codableRequires anatomic location (for example - specify anal). Also "epithelial disruption" does not map to any specific term in MedDRA and would generate query. Alternatives could include "ulcer", "erosion", "excoriation", or "abrasion".mucosal disruptionnot codableSee "epithelial disruption" ................
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