ID

20813

Description

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product. NCT01618370

Mots-clés

Versions (1)
  1. 20/03/2017 20/03/2017 -
Téléchargé le

20 mars 2017

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.

Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases (Study Medication)

Anglais

Radium 223 Dichloride (Alpharadin) - Study Medication

1 Formulaires  
Study Drug Exposure, radioactive material
Description

Study Drug Exposure, radioactive material

Did the subject take any Study Drug?
Description

Study drug

Type de données

boolean

Alias
UMLS CUI [1]
C0304229
Study drug
Description

Study drug

Type de données

text

Alias
UMLS CUI [1]
C0304229
Assessment period
Description

Assessment period

Type de données

text

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C1948053
Start Date
Description

Start Date

Type de données

date

Alias
UMLS CUI [1]
C0808070
Start time
Description

(24-hour clock)

Type de données

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Description

Stop Date

Type de données

date

Alias
UMLS CUI [1]
C0806020
Planned dose
Description

Planned dose

Type de données

text

Unités de mesure
  • kBq/kg body weight
Alias
UMLS CUI [1]
C2826283
kBq/kg body weight
Weight
Description

Weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Decay Correction factor
Description

Decay Correction factor

Type de données

text

Alias
UMLS CUI [1]
C3166265
Declared activity of Study Drug
Description

Declared activity of Study Drug

Type de données

text

Unités de mesure
  • kBq/mL
Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0599112
kBq/mL
Calculated Volume to be injected
Description

Volume

Type de données

text

Unités de mesure
  • ml
Alias
UMLS CUI [1,1]
C0449468
UMLS CUI [1,2]
C0444686
ml
Calculated Radioactivity to be injected
Description

Calculated Radioactivity

Type de données

text

Unités de mesure
  • kBq
Alias
UMLS CUI [1,1]
C0444686
UMLS CUI [1,2]
C0034553
kBq
Actual volume in syringe before injection
Description

volume in syringe before injection

Type de données

text

Unités de mesure
  • ml
Alias
UMLS CUI [1,1]
C4071537
UMLS CUI [1,2]
C0585032
ml
Radioactivity in syringe before injection
Description

Radioactivity in syringe

Type de données

text

Unités de mesure
  • kBq
Alias
UMLS CUI [1,1]
C0034553
UMLS CUI [1,2]
C1706071
UMLS CUI [1,3]
C0585032
kBq
Radioactivity in syringe after injection
Description

Radioactivity in syringe

Type de données

text

Unités de mesure
  • kBq
Alias
UMLS CUI [1,1]
C0034553
UMLS CUI [1,2]
C1706071
UMLS CUI [1,3]
C0580203
kBq
Actual volume in syringe after injection
Description

volume in syringe after injection

Type de données

text

Unités de mesure
  • ml
Alias
UMLS CUI [1,1]
C4071537
UMLS CUI [1,2]
C0580203
ml
Dose modification 1
Description

Dose modification

Type de données

text

Alias
UMLS CUI [1]
C1707811
Reason for dose modification 1
Description

Dose modification reason

Type de données

text

Alias
UMLS CUI [1,1]
C1707811
UMLS CUI [1,2]
C0392360
If Adverse event, select up to 3 most important AEs:
Description

Dynamic search list contains: "Number - Term - Start Date"

Type de données

text

Alias
UMLS CUI [1]
C0877248
If Other, specify
Description

If Other, specify

Type de données

text

Alias
UMLS CUI [1]
C3840932
Retour au début de la page

Similar models

Radium 223 Dichloride (Alpharadin) - Study Medication

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Study Drug Exposure, radioactive material
Study drug
Item
Did the subject take any Study Drug?
boolean
C0304229 (UMLS CUI [1])
Study drug
Item
Study drug
text
C0304229 (UMLS CUI [1])
Assessment period
Item
Assessment period
text
C0220825 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Planned dose
Item
Planned dose
text
C2826283 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Decay Correction factor
Item
Decay Correction factor
text
C3166265 (UMLS CUI [1])
Declared activity of Study Drug
Item
Declared activity of Study Drug
text
C3854006 (UMLS CUI [1,1])
C0599112 (UMLS CUI [1,2])
Volume
Item
Calculated Volume to be injected
text
C0449468 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
Calculated Radioactivity
Item
Calculated Radioactivity to be injected
text
C0444686 (UMLS CUI [1,1])
C0034553 (UMLS CUI [1,2])
volume in syringe before injection
Item
Actual volume in syringe before injection
text
C4071537 (UMLS CUI [1,1])
C0585032 (UMLS CUI [1,2])
Radioactivity in syringe
Item
Radioactivity in syringe before injection
text
C0034553 (UMLS CUI [1,1])
C1706071 (UMLS CUI [1,2])
C0585032 (UMLS CUI [1,3])
Radioactivity in syringe
Item
Radioactivity in syringe after injection
text
C0034553 (UMLS CUI [1,1])
C1706071 (UMLS CUI [1,2])
C0580203 (UMLS CUI [1,3])
volume in syringe after injection
Item
Actual volume in syringe after injection
text
C4071537 (UMLS CUI [1,1])
C0580203 (UMLS CUI [1,2])
Dose modification
Item
Dose modification 1
text
C1707811 (UMLS CUI [1])
Dose modification reason
Item
Reason for dose modification 1
text
C1707811 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Adverse event
Item
If Adverse event, select up to 3 most important AEs:
text
C0877248 (UMLS CUI [1])
If Other, specify
Item
If Other, specify
text
C3840932 (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