ID

34100

Description

tudy ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Mots-clés

Versions (1)
  1. 2019-01-14 2019-01-14 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

14 januari 2019

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.

Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)

Anglais

24hrs Ambulatory Blood Pressure Monitoring

1 Formulaires  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Session number
Description

Session number 1 means screening procedure.

Type de données

integer

Alias
UMLS CUI [1,1]
C1883017
UMLS CUI [1,2]
C0750480
Day number
Description

Day numbers can only be selected in Session 2.

Type de données

integer

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0439228
Time documentation
Description

Time documentation

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0920316
UMLS CUI-3
C0026426
Start date
Description

Start date

Type de données

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0026426
Actual time monitoring commenced
Description

Actual time monitoring commenced

Type de données

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0026426
Stop date
Description

Stop date

Type de données

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0026426
Actual time monitoring completed
Description

Actual time monitoring completed

Type de données

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0026426
24hrs Ambulatory Blood pressure monitoring
Description

24hrs Ambulatory Blood pressure monitoring

Alias
UMLS CUI-1
C0026426
UMLS CUI-2
C0549178
UMLS CUI-3
C0439841
Row number
Description

Row number 1 refers to 0hr-12hrs, Row number 2 refers to 12hrs-24hrs.

Type de données

integer

Alias
UMLS CUI [1]
C2348184
Planned relative time
Description

Time relative dosing

Type de données

text

Alias
UMLS CUI [1]
C0439564
Maximum systolic blood pressure
Description

Maximum systolic blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0806909
mmHg
Time of maximum systolic blood pressure
Description

Time of maximum systolic blood pressure

Type de données

time

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C0040223
Maximum diastolic blood pressure
Description

Maximum diastolic blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0806909
mmHg
Time of maximum diastolic blood pressure
Description

Time of maximum diastolic blood pressure

Type de données

time

Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C0040223
Minimum systolic blood pressure
Description

Minimum systolic blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C1524031
mmHg
Time of minimum systolic blood pressure
Description

Time of minimum systolic blood pressure

Type de données

time

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C1524031
UMLS CUI [1,3]
C0040223
Mean systolic blood pressure
Description

Mean systolic blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0444504
mmHg
Mean diastolic blood pressure
Description

Mean diastolic blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0444504
mmHg
Maximum MAP
Description

MAP means Mean arterial pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0428886
UMLS CUI [1,2]
C0806909
mmHg
Minimum MAP
Description

MAP means Mean arterial pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0428886
UMLS CUI [1,2]
C1524031
mmHg
Mean MAP
Description

MAP means Mean arterial pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0428886
UMLS CUI [1,2]
C0444504
mmHg
Abnormalities
Description

Abnormalities

Alias
UMLS CUI-1
C1704258
UMLS CUI-2
C0026426
Were any clinically significant abnormalities observed?
Description

If YES, EXCLUDE subject from the study.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2985739
Retour au début de la page

Similar models

24hrs Ambulatory Blood Pressure Monitoring

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Session number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Session number
Code List
Session number
CL Item
1 (1)
CL Item
2 (2)
Item
Day number
integer
C0750729 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Day number
Code List
Day number
CL Item
2 (2)
(Comment:en)
CL Item
4 (4)
(Comment:en)
CL Item
6 (6)
(Comment:en)
CL Item
9 (9)
(Comment:en)
CL Item
11 (11)
(Comment:en)
CL Item
13 (13)
(Comment:en)
Item Group
Time documentation
C0040223 (UMLS CUI-1)
C0920316 (UMLS CUI-2)
C0026426 (UMLS CUI-3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
Actual time monitoring commenced
Item
Actual time monitoring commenced
time
C1301880 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
Actual time monitoring completed
Item
Actual time monitoring completed
time
C1522314 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
Item Group
24hrs Ambulatory Blood pressure monitoring
C0026426 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
C0439841 (UMLS CUI-3)
Item
Row number
integer
C2348184 (UMLS CUI [1])
Row number
Code List
Row number
CL Item
1 (1)
CL Item
2 (2)
Item
Planned relative time
text
C0439564 (UMLS CUI [1])
Planned relative time
Code List
Planned relative time
CL Item
0hr-12hrs (0hr-12hrs)
CL Item
12hrs-24hrs (12hrs-24hrs)
Maximum systolic blood pressure
Item
Maximum systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Time of maximum systolic blood pressure
Item
Time of maximum systolic blood pressure
time
C0871470 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Maximum diastolic blood pressure
Item
Maximum diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Time of maximum diastolic blood pressure
Item
Time of maximum diastolic blood pressure
time
C0428883 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Minimum systolic blood pressure
Item
Minimum systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Time of minimum systolic blood pressure
Item
Time of minimum systolic blood pressure
time
C0871470 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Mean systolic blood pressure
Item
Mean systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Mean diastolic blood pressure
Item
Mean diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Maximum MAP
Item
Maximum MAP
integer
C0428886 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Minimum MAP
Item
Minimum MAP
integer
C0428886 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Mean MAP
Item
Mean MAP
integer
C0428886 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Item Group
Abnormalities
C1704258 (UMLS CUI-1)
C0026426 (UMLS CUI-2)
Clinically significant abnormalities
Item
Were any clinically significant abnormalities observed?
boolean
C0026426 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial