ID

39530

Description

Study ID: 110852 Clinical Study ID: 110852 Study Title: MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01134055 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib eye drops, ranibizumab intravitreal injection, placebo Trade Name: pazopanib, ranibizumab Study Indication: Macular Degeneration

Mots-clés

Klinische Studie [Dokumenttyp]

Auge

23/01/2020 23/01/2020 -

Détendeur de droits

GlaxoSmithKline

Téléchargé le

23 janvier 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055

model
Détails

Screen - Eye Lid and Lash Exam; Conjunctival Exam; Corneal Exam

1 Formulaires

StudyEvent: ODM
1. Screen - Eye Lid and Lash Exam; Conjunctival Exam; Corneal Exam

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Eye Lid and Lash Exam

Item Group

Eye Lid and Lash Exam

C0031809 (UMLS CUI-1)
C0015392 (UMLS CUI-2)
C2706046 (UMLS CUI-3)

Eye Lid and Lash Exam - Assessment date

Item

Eye Lid and Lash Exam - Assessment date

date

C0031809 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
C2706046 (UMLS CUI [1,3])
C2985720 (UMLS CUI [2])

Right Upper Eye Lid

Item

Right Upper Eye Lid

text

C0229089 (UMLS CUI [1,1])
C0585636 (UMLS CUI [1,2])

Examination of Eye Lids and Lashes - Right Upper Eye Lid

Code List

Right Upper Eye Lid

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Ptosis (UELPTSIS)

CL Item

Retraction (UELRTRAC)

CL Item

Benign eye lid leason (UELBLLS)

CL Item

Other, Specify (?)

If other finding of right upper eye lid, sepcify

Item

If other finding of right upper eye lid, sepcify

text

C0229089 (UMLS CUI [1,1])
C0585636 (UMLS CUI [1,2])
C0243095 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])

Right Lower Eye Lid

Item

Right Lower Eye Lid

text

C0229089 (UMLS CUI [1,1])
C2706046 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])

Examination of Eye Lids and Lashes - Right Lower Eye Lid

Code List

Right Lower Eye Lid

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Entropion (LELENTP)

CL Item

Ectropion (LELECTP)

CL Item

Benign eye lid lesions (LELBLLS)

CL Item

Other, specify (?)

If other finding of right lower eye lid, specify

Item

If other finding of right lower eye lid, specify

text

C0229089 (UMLS CUI [1,1])
C2706046 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C0243095 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])

Meibomian Gland Dysfunction Right Eye

Item

Meibomian Gland Dysfunction Right Eye

integer

C1275684 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])

Examination of Eye Lids and Lashes - Meibomian Gland Dysfunction Right Eye

Code List

Meibomian Gland Dysfunction Right Eye

CL Item

Absent (0)

CL Item

Present (1)

CL Item

Mild inspisation/debris without injection or thickening (11)

CL Item

Obvious inspisation/debris, mild injection, no trichiasis or lid thickening (12)

CL Item

Inspisation, debris, obvious injection, lid thickening, may have trichiasis (13)

Right Eye Eyelid margin

Item

Right Eye Eyelid margin

text

C0444582 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])

Right Eye Eyelid margin

Code List

Right Eye Eyelid margin

CL Item

Normal (N)

CL Item

Abnormal (A)

CL Item

Crusting/ discharge (1)

CL Item

Erythema (2)

CL Item

Teleangiectatic blood vessels (3)

CL Item

Other, specify (OT)

If other finding of eyelid margin of right eye, specify

Item

If other finding of eyelid margin of right eye, specify

text

C0444582 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C0243095 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])

Left Upper Eye Lid

Item

Left Upper Eye Lid

text

C0229090 (UMLS CUI [1,1])
C0585636 (UMLS CUI [1,2])

Right Upper Eye Lid

Code List

Left Upper Eye Lid

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Ptosis (UELPTSIS)

CL Item

Retraction (UELRTRAC)

CL Item

Benign eye lid leason (UELBLLS)

CL Item

Other, Specify (?)

If other finding of left upper eye lid, sepcify

Item

If other finding of left upper eye lid, sepcify

text

C0229090 (UMLS CUI [1,1])
C0585636 (UMLS CUI [1,2])
C0243095 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])

Left Lower Eye Lid

Item

Left Lower Eye Lid

text

C0229090 (UMLS CUI [1,1])
C2706046 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])

Left Lower Eye Lid

Code List

Left Lower Eye Lid

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Entropion (LELENTP)

CL Item

Ectropion (LELECTP)

CL Item

Benign eye lid lesions (LELBLLS)

CL Item

Other, specify (?)

If other finding of left lower eye lid, specify

Item

If other finding of left lower eye lid, specify

text

C0229090 (UMLS CUI [1,1])
C2706046 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C0243095 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])

Meibomian Gland Dysfunction Left Eye

Item

Meibomian Gland Dysfunction Left Eye

text

C1275684 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])

Meibomian Gland Dysfunction Left Eye

Code List

Meibomian Gland Dysfunction Left Eye

CL Item

Absent (0)

CL Item

Present (1)

CL Item

Mild inspisation/debris without injection or thickening (11)

CL Item

Obvious inspisation/debris, mild injection, no trichiasis or lid thickening (12)

CL Item

Inspisation, debris, obvious injection, lid thickening, may have trichiasis (13)

Left Eye Eyelid margin

Item

Left Eye Eyelid margin

text

C0444582 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])

Left Eye Eyelid margin

Code List

Left Eye Eyelid margin

CL Item

Normal (N)

CL Item

Abnormal (A)

CL Item

Crusting/ discharge (1)

CL Item

Erythema (2)

CL Item

Teleangiectatic blood vessels (3)

CL Item

Other, specify (OT)

If other finding of eyelid margin of left eye, specify

Item

If other finding of eyelid margin of left eye, specify

text

C0444582 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
C0243095 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])

Conjunctival Exam

Item Group

Conjunctival Exam

C0009758 (UMLS CUI-1)
C0031809 (UMLS CUI-2)

Conjunctival Exam - Assessment date

Item

Conjunctival Exam - Assessment date

date

C0009758 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C2985720 (UMLS CUI [2])

Conjunctival Injection Right Eye

Item

Conjunctival Injection Right Eye

text

C2675806 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])

Conjunctival Injection Right Eye

Code List

Conjunctival Injection Right Eye

CL Item

Normal (N)

CL Item

Abnormal (A)

CL Item

Prominence of conjunctival vessels without ciliary injection, episcleral injection, or gross dilation of vessels (1)

CL Item

Obvious dilation of conjunctival vessels, may have mild ciliary injection, no episcleral injection, no hemorrhage (2)

CL Item

Severe injection, ciliary injection, may have subconjunctival hemorrhage or episcleral injection (3)

Chemosis Right Eye

Item

Chemosis Right Eye

text

C0271298 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])

Chemosis Right Eye

Code List

Chemosis Right Eye

CL Item

Normal (N)

CL Item

Abnormal (A)

CL Item

Slight edema, localized or not diffuse (1)

CL Item

Diffuse edema, but clear serous fluid without significant prolapse over the lower lid (2)

CL Item

Diffuse edema with hazy subconjunctival fluid and significant prolapse of conjunctiva over the lower lids (3)

Conjunctival Injection Left Eye

Item

Conjunctival Injection Left Eye

text

C2675806 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])

Conjunctival Injection Left Eye

Code List

Conjunctival Injection Left Eye

CL Item

Normal (N)

CL Item

Abnormal (A)

CL Item

Prominence of conjunctival vessels without ciliary injection, episcleral injection, or gross dilation of vessels (1)

CL Item

Obvious dilation of conjunctival vessels, may have mild ciliary injection, no episcleral injection, no hemorrhage (2)

CL Item

Severe injection, ciliary injection, may have subconjunctival hemorrhage or episcleral injection (3)

Chemosis Left Eye

Item

Chemosis Left Eye

text

C0271298 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])

Chemosis Left Eye

Code List

Chemosis Left Eye

CL Item

Normal (N)

CL Item

Abnormal (A)

CL Item

Slight edema, localized or not diffuse (1)

CL Item

Diffuse edema, but clear serous fluid without significant prolapse over the lower lid (2)

CL Item

Diffuse edema with hazy subconjunctival fluid and significant prolapse of conjunctiva over the lower lids (3)

Corneal Exam

Item Group

Corneal Exam

C0010031 (UMLS CUI-1)
C0031809 (UMLS CUI-2)

Corneal Exam - Assessment Date

Item

Corneal Exam - Assessment Date

date

C0010031 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])

Corneal epithelium Right Eye

Item

Corneal epithelium Right Eye

text

C0459875 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])

Corneal epithelium Right Eye

Code List

Corneal epithelium Right Eye

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Punctate keratopathy (21)

CL Item

Epithelial edema (22)

CL Item

Other, specify (OT)

If punctate keratopathy of right eye, specify

Item

If punctate keratopathy of right eye, specify

integer

C0423234 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

If punctate keratopathy of right eye, specify

Code List

If punctate keratopathy of right eye, specify

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

If epithelial edema of right eye, specify

Item

If epithelial edema of right eye, specify

integer

C2137354 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

If epithelial edema of right eye, specify

Code List

If epithelial edema of right eye, specify

CL Item

Subtle epithelial haze (1)

CL Item

Mild patchy microcystic changes (2)

CL Item

Diffuse microsystic changes (3)

If other corneal epithelium finding of right eye, specify

Item

If other corneal epithelium finding of right eye, specify

text

C0459875 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C0243095 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])

Stroma Right Eye

Item

Stroma Right Eye

integer

C0010040 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])

Stroma Right Eye

Code List

Stroma Right Eye

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Active opacity (21)

CL Item

Active edema (22)

CL Item

Other, specify (23)

Select grade of active opacity of right eye

Item

Select grade of active opacity of right eye

integer

C0010038 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])

Select grade of active opacity of right eye

Code List

Select grade of active opacity of right eye

CL Item

Mild (5)

CL Item

Moderate (6)

CL Item

Severe (7)

Select grade of active edema of right eye

Item

Select grade of active edema of right eye

integer

C2137357 (UMLS CUI [1])

Select grade of active edema of right eye

Code List

Select grade of active edema of right eye

CL Item

Trace (0)

CL Item

1+ (1)

CL Item

2+ (2)

CL Item

3+ (3)

CL Item

4+ (4)

If other finding of stroma of right eye, specify

Item

If other finding of stroma of right eye, specify

text

C0010040 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C0243095 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])

Corneal Staining Right Eye

Item

Corneal Staining Right Eye

integer

C0423232 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])

Corneal Staining Right Eye

Code List

Corneal Staining Right Eye

CL Item

None (0)

CL Item

Few (<5) punctate areas of epithelial staining (1)

CL Item

Obvious (< or = 20) localized or diffuse punctate staining (2)

CL Item

Severe localized or diffuse punctate staining (3)

Corneal endothelium Right Eye

Item

Corneal endothelium Right Eye

text

C0014259 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])

Corneal endothelium Right Eye

Code List

Corneal endothelium Right Eye

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Guttata (21)

CL Item

Descement's folds (22)

CL Item

Other, specify (OT)

If other corneal endothelium of right eye, specify

Item

If other finding corneal endothelium of right eye, specify

text

C0014259 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C0243095 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])

Corneal epithelium Left Eye

Item

Corneal epithelium Left Eye

text

C0459875 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])

Corneal epithelium Left Eye

Code List

Corneal epithelium Left Eye

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Punctate keratopathy (21)

CL Item

Epithelial edema (22)

CL Item

Other, specify (OT)

If punctate keratopathy of left eye, specify

Item

If punctate keratopathy of left eye, specify

integer

C0423234 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

If punctate keratopathy of left eye, specify

Code List

If punctate keratopathy of left eye, specify

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

If epithelial edema of left eye, specify

Item

If epithelial edema of left eye, specify

integer

C2137346 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

If epithelial edema of left eye, specify

Code List

If epithelial edema of left eye, specify

CL Item

Subtle epithelial haze (1)

CL Item

Mild patchy microcystic changes (2)

CL Item

Diffuse microsystic changes (3)

If other corneal epithelium finding of left eye, specify

Item

If other corneal epithelium finding of left eye, specify

text

C0459875 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
C0243095 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])

Stroma Left Eye

Item

Stroma Left Eye

integer

C0010040 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])

Stroma Left Eye

Code List

Stroma Left Eye

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Active opacity (21)

CL Item

Active edema (22)

CL Item

Other, specify (23)

Select grade of active opacity of left eye

Item

Select grade of active opacity of left eye

integer

C0010038 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])

Select grade of active opacity of left eye

Code List

Select grade of active opacity of left eye

CL Item

Mild (5)

CL Item

Moderate (6)

CL Item

Severe (7)

Select grade of active edema of left eye

Item

Select grade of active edema of left eye

text

C2137349 (UMLS CUI [1])

Select grade of active edema of left eye

Code List

Select grade of active edema of left eye

CL Item

Trace (0)

CL Item

1+ (1)

CL Item

2+ (2)

CL Item

3+ (3)

CL Item

4+ (4)

If other finding of stroma of left eye, specify

Item

If other finding of stroma of left eye, specify

text

C0010040 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
C0243095 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])

Corneal Staining Left Eye

Item

Corneal Staining Left Eye

integer

C0423232 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])

Corneal Staining Left Eye

Code List

Corneal Staining Left Eye

CL Item

None (0)

CL Item

Few (<5) punctate areas of epithelial staining (1)

CL Item

Obvious (< or = 20) localized or diffuse punctate staining (2)

CL Item

Severe localized or diffuse punctate staining (3)

Corneal endothelium Left Eye

Item

Corneal endothelium Left Eye

text

C0014259 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])

Corneal endothelium Left Eye

Code List

Corneal endothelium Left Eye

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Guttata (21)

CL Item

Descement's folds (22)

CL Item

Other, specify (OT)

If other finding corneal endothelium of left eye, specify

Item

If other finding corneal endothelium of left eye, specify

text

C0014259 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
C0243095 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])

Retour au début de la page

ID

Description

Mots-clés

Versions (1)

Détendeur de droits

Téléchargé le

DOI

Licence

Modèle Commentaires :

Groupe Item commentaires pour :

Item commentaires pour :

Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055

Screen - Eye Lid and Lash Exam; Conjunctival Exam; Corneal Exam

Description

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Alias

Description