ID

38812

Description

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Mots-clés

Versions (1)
  1. 05/11/2019 05/11/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

5 novembre 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 single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933

Anglais

Vital Signs (Period 1 - 5; Day 1 - Day 13)

1 Formulaires  
Vital Signs (Period 1 - 5) - Dosing date/ time
Description

Vital Signs (Period 1 - 5) - Dosing date/ time

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0178602
UMLS CUI-3
C1264639
Vital Signs (Period 1 - 5) - Dosing date/ time
Description

Vital Signs (Period 1 - 5) - Dosing date/ time

Type de données

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
Vital Signs (Period 1 -5)
Description

Vital Signs (Period 1 -5)

Alias
UMLS CUI-1
C0518766
Vital Signs - Timepoint
Description

Vital Signs - Timepoint

Type de données

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2348792
Actual date/ time
Description

Actual date/ time

Type de données

datetime

Alias
UMLS CUI [1]
C1264639
Systolic Blood pressure
Description

Systolic Blood pressure

Type de données

integer

Unités de mesure
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood pressure
Description

Diastolic Blood pressure

Type de données

integer

Unités de mesure
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate
Description

Heart rate

Type de données

integer

Unités de mesure
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Body Temperature
Description

Body Temperature

Type de données

float

Unités de mesure
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Vital Signs (Day 1 - 13) - Dosing date/ time
Description

Vital Signs (Day 1 - 13) - Dosing date/ time

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0178602
UMLS CUI-3
C1264639
AM Dosing date/ time
Description

AM Dosing date/ time

Type de données

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C4331833
PM Dosing date/ time
Description

PM Dosing date/ time

Type de données

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C1509133
Vital Signs (Day 1 - 13)
Description

Vital Signs (Day 1 - 13)

Alias
UMLS CUI-1
C0518766
Vital Signs - Timepoint
Description

Vital Signs - Timepoint

Type de données

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2348792
Actual date/ time
Description

Actual date/ time

Type de données

datetime

Alias
UMLS CUI [1]
C1264639
Systolic Blood pressure
Description

Systolic Blood pressure

Type de données

integer

Unités de mesure
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood pressure
Description

Diastolic Blood pressure

Type de données

integer

Unités de mesure
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate
Description

Heart rate

Type de données

integer

Unités de mesure
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Body Temperature
Description

Body Temperature

Type de données

float

Unités de mesure
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Retour au début de la page

Similar models

Vital Signs (Period 1 - 5; Day 1 - Day 13)

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Vital Signs (Period 1 - 5) - Dosing date/ time
C0518766 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
Vital Signs (Period 1 - 5) - Dosing date/ time
Item
Vital Signs (Period 1 - 5) - Dosing date/ time
datetime
C0518766 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
Vital Signs (Period 1 -5)
C0518766 (UMLS CUI-1)
Item
Vital Signs - Timepoint
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Vital Signs - Timepoint
Code List
Vital Signs - Timepoint
CL Item
Pre dose 1 (1)
CL Item
Pre dose 2 (2)
CL Item
Pre dose 3 (3)
CL Item
30 mins (4)
CL Item
1 hr (5)
CL Item
2 hr (6)
CL Item
4 hr (7)
CL Item
6 hr (8)
CL Item
8 hr (9)
CL Item
12 hr (10)
CL Item
24 hr (11)
Actual date/ time
Item
Actual date/ time
datetime
C1264639 (UMLS CUI [1])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Vital Signs (Day 1 - 13) - Dosing date/ time
C0518766 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
AM Dosing date/ time
Item
AM Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C4331833 (UMLS CUI [1,3])
PM Dosing date/ time
Item
PM Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1509133 (UMLS CUI [1,3])
Item Group
Vital Signs (Day 1 - 13)
C0518766 (UMLS CUI-1)
Item
Vital Signs - Timepoint
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Vital Signs - Timepoint
Code List
Vital Signs - Timepoint
CL Item
Pre dose 1 (1)
CL Item
Pre dose 2 (2)
CL Item
Pre dose 3 (3)
CL Item
30 mins (4)
CL Item
2 hr (5)
CL Item
4 hr (6)
CL Item
8 hr (7)
CL Item
12 hr (8)
CL Item
12 hr:30 mins (9)
CL Item
14 hr (10)
CL Item
16 hr/ not done (11)
CL Item
20 hr/ not done (12)
CL Item
24 hr (13)
Actual date/ time
Item
Actual date/ time
datetime
C1264639 (UMLS CUI [1])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
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