ID

44018

Description

Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen of ropinirole in patients suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome Dose Level 1 (Day 1)

Keywords

Versions (2)
  1. 8/4/17 8/4/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC-ND 3.0
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Dose Level 1 GSK Ropinirole Restless Legs Syndrome 101468

English

Dose Level 1 GSK Ropinirole Restless Legs Syndrome 101468

1 forms  
Patient Information
Description

Patient Information

Alias
UMLS CUI-1
C1955348
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Day
Description

Visit Day

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C2827038
dd-mmm-yyyy
Predose Checklist - Instructions: Please mark appropriateanswer to the following questions. If the answer to all the questions is YES then dosing may proceed.
Description

Predose Checklist - Instructions: Please mark appropriateanswer to the following questions. If the answer to all the questions is YES then dosing may proceed.

Alias
UMLS CUI-1
C0439565
UMLS CUI-2
C1707357
1. Has the patient washed out from their previous RLS medication for the appropriate length of time (DAY 1)?
Description

Date of last RLS medication

Data type

boolean

Alias
UMLS CUI [1,1]
C4029433
UMLS CUI [1,2]
C0035258
2. Has the patient refrained from consuming alcohol from midnight prior to the clinic visit?
Description

Last Alcohol Consumption

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C1517741
3. Has the patient limited their daily consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, 1.5 ounces of hard liquor or 1 small glass of wine.)
Description

Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
4. Has the patient refrained from strenuous exercise (outside of normal routine) from 24 hours before the clinic visit?
Description

Strenuous Exercise

Data type

boolean

Alias
UMLS CUI [1]
C1514989
5. Has the patient maintained their normal smoking practice?
Description

Smoking Status

Data type

boolean

Alias
UMLS CUI [1]
C1519386
6. Has the patient refrained from caffeine-containing beverages from 12 noon on the day of the clinic visit?
Description

Caffeinated beverage

Data type

boolean

Alias
UMLS CUI [1]
C0678438
7. Has the patient refrained from taking other medication (OTC or herbal remedies) for 48 hours prior to the clinic visit? Patients who have taken OTC medication may still be able to continue in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
Description

OTC or herbal remedies

Data type

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0025125
8. For the concomitant medication which are CYP1A2 inducers, substrated or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy or oestrogen containing medications)
Description

Concomitant Medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
RLS Rating Scale
Description

RLS Rating Scale

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C0035258
RLS Rating Scale
Description

RLS Rating Scale

Data type

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
Prior Medication
Description

Prior Medication

Alias
UMLS CUI-1
C2826257
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
Description

If 'YES', please record the medication below. NB: Any medications Metabolised by CYP1A2 must be kept constant through out the study.

Data type

boolean

Alias
UMLS CUI [1]
C2826257
Drug Name (Trade Name Preferred)
Description

Drug name

Data type

text

Alias
UMLS CUI [1]
C0013227
SINGLE Dose/Unit (e.g. 500mg)
Description

Dose

Data type

text

Alias
UMLS CUI [1]
C3174092
Frequency of this (e.g. BID, PRN)
Description

Medication Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Administration Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Duration of Therapy (e.g. 6 years)
Description

Duration of Therapy

Data type

text

Alias
UMLS CUI [1]
C0444921
End Date
Description

End Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0806020
dd-mmm-yyyy
Continuing at end of study?
Description

Continuing

Data type

boolean

Alias
UMLS CUI [1]
C1553904
Pregnancy Test (Females only)
Description

Pregnancy Test (Females only)

Alias
UMLS CUI-1
C0032976
Was a pregnancy test carried out?
Description

Pregnancy Test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
If 'NO', please specify reason
Description

Reason for Pregnancy Test

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0032976
If ´YES´, please indicate date of result:
Description

Date of Pregnany Test

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0032976
dd-mmm-yyyy
If ´YES´, please indicate the result:
Description

If 'POSITIVE', withdraw the subject from the study.

Data type

text

Alias
UMLS CUI [1]
C0427777
Vital Signs - Instructions: Semi-supine recordings must be made after the patient has been resting semi-supine for at least 10 min & erect measurments will be taken after the patients has been erect for a period of 1 min. Three sets of stable semi-supine and errect vital signs must be recorded pre-dose with the patient resting fro 10 min semi-supine between each set. In this instance 'stable' is defined at all measurements being within 15 mmHg of the lowest measurements for each and every parameter e.g. semi-supine diastolic. - The blood pressure cuff must be placed on the same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.
Description

Vital Signs - Instructions: Semi-supine recordings must be made after the patient has been resting semi-supine for at least 10 min & erect measurments will be taken after the patients has been erect for a period of 1 min. Three sets of stable semi-supine and errect vital signs must be recorded pre-dose with the patient resting fro 10 min semi-supine between each set. In this instance 'stable' is defined at all measurements being within 15 mmHg of the lowest measurements for each and every parameter e.g. semi-supine diastolic. - The blood pressure cuff must be placed on the same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
Date
Description

Date of Examination: Pre-Dose

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2826643
UMLS CUI [1,2]
C0439565
dd-mmm-yyyy
Time
Description

Time of Examination: Pre-Dose

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0439565
24hr:min
Semi-supine Blood Pressure: Systolic
Description

Semi-supine Systolic Blood Pressure: Pre-Dose

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0871470
UMLS CUI [1,3]
C0439565
mmHg
Semi-supine Blood Pressure: Diastolic
Description

Semi-supine Diastolic Blood Pressure: Pre-Dose

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0428883
UMLS CUI [1,3]
C0439565
mmHg
Semi-supine Heart Rate
Description

Semi-supine Heart Rate: Pre-Dose

Data type

float

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C0439565
bpm
Erect Blood Pressure: Systolic
Description

Erect Systolic Blood Pressure: Pre-Dose

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0871470
UMLS CUI [1,3]
C0439565
mmHg
Erect Blood Pressure: Diastolic
Description

Erect Diastolic Blood Pressure: Pre-Dose

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0428883
UMLS CUI [1,3]
C0439565
mmHg
Erect Heart Rate
Description

Erect Heart Rate: Pre-Dose

Data type

float

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0018810
bpm
Baseline Signs and Symptoms - Please note any SERIOUS events should be recorded on this page, but on the Serious Adverse Event pages provided. Record any Baseline events (using standard medical terminology) observed or elicited by the following direct question to subject: "How do you feel?" Provide the diagnosis, NOT symptoms where possible. (One baseline event per column)
Description

Baseline Signs and Symptoms - Please note any SERIOUS events should be recorded on this page, but on the Serious Adverse Event pages provided. Record any Baseline events (using standard medical terminology) observed or elicited by the following direct question to subject: "How do you feel?" Provide the diagnosis, NOT symptoms where possible. (One baseline event per column)

Alias
UMLS CUI-1
C0037088
If no baseline events experienced, please mark box and sign from below.
Description

No Baseline Signs and Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1518422
Baseline Signs and Symptoms
Description

Baseline Signs and Symptoms

Data type

text

Alias
UMLS CUI [1]
C0037088
Onset Date
Description

Date of Onset

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0574845
dd-mmm-yyyy
Onset Time
Description

Time of Onset

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1]
C0449244
24hr:min
End Date (If ongoing please leave blank)
Description

End Date of Baseline Signs and Symptoms

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0037088
dd-mmm-yyyy
End Time (If ongoing please leave blank)
Description

End Time of Baseline Signs and Symptoms

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0037088
24hr:min
Outcome
Description

* If subject died, please inform GSK within 24 hours and complete Form D

Data type

text

Alias
UMLS CUI [1]
C1547647
Event Course
Description

Event Course

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Event Course If Intermittent, specify No. of episodes
Description

Number of Episodes

Data type

integer

Alias
UMLS CUI [1]
C4086638
Intensity (maximum)
Description

MILD = The event which is easily tolerated MODERATE = An event which is sufficiently discomforting to interfere with daily activity SEVERE = An event which prevents normal everyday activities

Data type

text

Alias
UMLS CUI [1]
C0518690
Relationship to study procedures performed prior to randomisation
Description

NOT RELATED = The event is definetly not related to the study procedures UNLIKELY = There are other more likely causes and the study procedures are not suspected as a cause SUSPECTEED (REASONABLE POSSIBILITY) = A direct cause and effect relationship between the study procedures and the event has not been demonstrated but there is a reasonable possibility that the study procedures were involved PROBABLE = There probably is a direct cause and effect relationship beween and the study procedures

Data type

text

Alias
UMLS CUI [1]
C0439849
Corrective Therapy (If 'YES', Please record on Prior Medication form)
Description

Corrective Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0087111
Was subject withdrawn due to this event?
Description

Withdrawal

Data type

boolean

Alias
UMLS CUI [1]
C2349954
Dosing Details
Description

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Was afternoon meal/snack eaten before dosing?
Description

Afternoon meal

Data type

boolean

Alias
UMLS CUI [1,1]
C0439550
UMLS CUI [1,2]
C1998602
Meal finish date:
Description

Date of last food intake

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0578574
UMLS CUI [1,2]
C0011008
dd-mmm-yyyy
Time of last food intake
Description

Time of last food intake

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1]
C0578574
24hr:min
Date of dosing
Description

Date of Dosing

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
dd-mmm-yyyy
Time of dosing
Description

Time of Dosing

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
24hr:min
Please record the following details from the bottle: Container Number
Description

Container Number

Data type

text

Alias
UMLS CUI [1]
C0180098
Please remove the label from the medication carton and attach below:
Description

Label

Data type

text

Alias
UMLS CUI [1]
C0013191
Dose Level
Description

Dose Level

Data type

text

Alias
UMLS CUI [1]
C0178602
Dose checked and administered by:
Description

Doctor's Name

Data type

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0031831
Vital Signs Instructions: For each set, semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measurements will be taken after the patients has been erect for a period of 1 min. - The blood pressure cuff must be placed on same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.
Description

Vital Signs Instructions: For each set, semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measurements will be taken after the patients has been erect for a period of 1 min. - The blood pressure cuff must be placed on same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439568
Study Time: Repeat at:
Description

Study time: Post-Dose

Data type

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0439568
Date
Description

Date of Examination: Post-Dose

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2826643
UMLS CUI [1,2]
C0439568
dd-mmm-yyyy
Time
Description

Time of Examination: Post-Dose

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0043299
UMLS CUI [1,3]
C0439568
24hr:min
Semi-supine Blood Pressure: Systolic
Description

Semi-supine Systolic Blood Pressure: Post-Dose

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0871470
UMLS CUI [1,3]
C0439568
mmHg
Semi-supine Blood Pressure: Diastolic
Description

Semi-supine Diastolic Blood Pressure: Post-Dose

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0428883
UMLS CUI [1,3]
C0439568
mmHg
Semi-supine Heart Rate
Description

Semi-supine Heart Rate: Post-Dose

Data type

float

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C0439568
bpm
Erect Blood Pressure: Systolic
Description

Erect Systolic Blood Pressure: Post-Dose

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0871470
UMLS CUI [1,3]
C0439568
mmHg
Erect Blood Pressure: Diastolic
Description

Erect Diastolic Blood Pressure: Post-Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0428883
UMLS CUI [1,3]
C0439568
Erect Heart Rate
Description

Erect Heart Rate: Post-Dose

Data type

float

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C0439568
bpm
Adverse Event - Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient "How are you feeling" (pre-dose) and at subsequent schedules intervals post-dose: "Since you were last asked have you felt unwell or different from usual?" Provide the diagnosis NOT symptoms where possible.
Description

Adverse Event - Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient "How are you feeling" (pre-dose) and at subsequent schedules intervals post-dose: "Since you were last asked have you felt unwell or different from usual?" Provide the diagnosis NOT symptoms where possible.

Alias
UMLS CUI-1
C0877248
Time Point: Repeat at:
Description

Time Point

Data type

text

Any Adverse Events?
Description

* If 'YES' record all details on an Adverse Event page at back of CRF.

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Study Protocol
Description

Study Protocol

Alias
UMLS CUI-1
C2348563
In the Investigator's opinion, is it safe for the patient to continue dosing at home?
Description

Y - Ensure patient returns home with their study medication and diary card. N - Select a dosing strategy from options below and tick the relevant box.

Data type

text

If 'No', select a dosing strategy from options below and tick the relevant box:
Description

TRY AGAIN - Patient will receive the next days dose in the clinic. COmplete an Extra Clinic Visit section of the CRF for this visit. MTD DETERMINED - No further attempts at up titration will be made. Ensure patient returns home with medication for the previous dose level and diary card. Schedule the Last Visit (6 days later) so patients receive their last dose in the clinic. Complete Last Clinic Visit section in the CRF.

Data type

text

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Similar models

Dose Level 1 GSK Ropinirole Restless Legs Syndrome 101468

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Day
Item
Visit Day
date
C2827038 (UMLS CUI [1])
Item Group
Predose Checklist - Instructions: Please mark appropriateanswer to the following questions. If the answer to all the questions is YES then dosing may proceed.
C0439565 (UMLS CUI-1)
C1707357 (UMLS CUI-2)
Date of last RLS medication
Item
1. Has the patient washed out from their previous RLS medication for the appropriate length of time (DAY 1)?
boolean
C4029433 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Last Alcohol Consumption
Item
2. Has the patient refrained from consuming alcohol from midnight prior to the clinic visit?
boolean
C0001948 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
Alcohol consumption
Item
3. Has the patient limited their daily consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, 1.5 ounces of hard liquor or 1 small glass of wine.)
boolean
C0001948 (UMLS CUI [1])
Strenuous Exercise
Item
4. Has the patient refrained from strenuous exercise (outside of normal routine) from 24 hours before the clinic visit?
boolean
C1514989 (UMLS CUI [1])
Smoking Status
Item
5. Has the patient maintained their normal smoking practice?
boolean
C1519386 (UMLS CUI [1])
Caffeinated beverage
Item
6. Has the patient refrained from caffeine-containing beverages from 12 noon on the day of the clinic visit?
boolean
C0678438 (UMLS CUI [1])
OTC or herbal remedies
Item
7. Has the patient refrained from taking other medication (OTC or herbal remedies) for 48 hours prior to the clinic visit? Patients who have taken OTC medication may still be able to continue in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
boolean
C0013231 (UMLS CUI [1])
C0025125 (UMLS CUI [2])
Concomitant Medication
Item
8. For the concomitant medication which are CYP1A2 inducers, substrated or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy or oestrogen containing medications)
boolean
C2347852 (UMLS CUI [1])
Item Group
RLS Rating Scale
C0681889 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
RLS Rating Scale
Item
RLS Rating Scale
text
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
Prior Medication
C2826257 (UMLS CUI-1)
Prior Medication
Item
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
boolean
C2826257 (UMLS CUI [1])
Drug name
Item
Drug Name (Trade Name Preferred)
text
C0013227 (UMLS CUI [1])
Dose
Item
SINGLE Dose/Unit (e.g. 500mg)
text
C3174092 (UMLS CUI [1])
Medication Frequency
Item
Frequency of this (e.g. BID, PRN)
text
C3476109 (UMLS CUI [1])
Administration Route
Item
Route
text
C0013153 (UMLS CUI [1])
Duration of Therapy
Item
Duration of Therapy (e.g. 6 years)
text
C0444921 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Continuing
Item
Continuing at end of study?
boolean
C1553904 (UMLS CUI [1])
Item Group
Pregnancy Test (Females only)
C0032976 (UMLS CUI-1)
Pregnancy Test
Item
Was a pregnancy test carried out?
boolean
C0032976 (UMLS CUI [1])
Reason for Pregnancy Test
Item
If 'NO', please specify reason
text
C0392360 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Date of Pregnany Test
Item
If ´YES´, please indicate date of result:
date
C0011008 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Item
If ´YES´, please indicate the result:
text
C0427777 (UMLS CUI [1])
Pregnancy Test Finding
Code List
If ´YES´, please indicate the result:
CL Item
Negative (Negative)
CL Item
Positive (Positive)
Item Group
Vital Signs - Instructions: Semi-supine recordings must be made after the patient has been resting semi-supine for at least 10 min & erect measurments will be taken after the patients has been erect for a period of 1 min. Three sets of stable semi-supine and errect vital signs must be recorded pre-dose with the patient resting fro 10 min semi-supine between each set. In this instance 'stable' is defined at all measurements being within 15 mmHg of the lowest measurements for each and every parameter e.g. semi-supine diastolic. - The blood pressure cuff must be placed on the same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Date of Examination: Pre-Dose
Item
Date
date
C2826643 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
Time of Examination: Pre-Dose
Item
Time
time
C0040223 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Semi-supine Systolic Blood Pressure: Pre-Dose
Item
Semi-supine Blood Pressure: Systolic
float
C0522019 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Semi-supine Diastolic Blood Pressure: Pre-Dose
Item
Semi-supine Blood Pressure: Diastolic
float
C0522019 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Semi-supine Heart Rate: Pre-Dose
Item
Semi-supine Heart Rate
float
C0522019 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Erect Systolic Blood Pressure: Pre-Dose
Item
Erect Blood Pressure: Systolic
float
C0522014 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Erect Diastolic Blood Pressure: Pre-Dose
Item
Erect Blood Pressure: Diastolic
float
C0522014 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Erect Heart Rate: Pre-Dose
Item
Erect Heart Rate
float
C0522014 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
Baseline Signs and Symptoms - Please note any SERIOUS events should be recorded on this page, but on the Serious Adverse Event pages provided. Record any Baseline events (using standard medical terminology) observed or elicited by the following direct question to subject: "How do you feel?" Provide the diagnosis, NOT symptoms where possible. (One baseline event per column)
C0037088 (UMLS CUI-1)
No Baseline Signs and Symptoms
Item
If no baseline events experienced, please mark box and sign from below.
boolean
C0037088 (UMLS CUI [1,1])
C1518422 (UMLS CUI [1,2])
Baseline Signs and Symptoms
Item
Baseline Signs and Symptoms
text
C0037088 (UMLS CUI [1])
Date of Onset
Item
Onset Date
date
C0574845 (UMLS CUI [1])
Time of Onset
Item
Onset Time
time
C0449244 (UMLS CUI [1])
End Date of Baseline Signs and Symptoms
Item
End Date (If ongoing please leave blank)
date
C0806020 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
End Time of Baseline Signs and Symptoms
Item
End Time (If ongoing please leave blank)
time
C1522314 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
Item
Outcome
text
C1547647 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Resolved (Resolved)
CL Item
Moderate (Moderate)
CL Item
Died* (Died*)
Item
Event Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Event Course
Code List
Event Course
CL Item
Intermittent (Intermittent)
CL Item
Constant (Constant)
Number of Episodes
Item
Event Course If Intermittent, specify No. of episodes
integer
C4086638 (UMLS CUI [1])
Item
Intensity (maximum)
text
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity (maximum)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Item
Relationship to study procedures performed prior to randomisation
text
C0439849 (UMLS CUI [1])
Relationship
Code List
Relationship to study procedures performed prior to randomisation
CL Item
Not related (Not related)
CL Item
Unlikely (Unlikely)
CL Item
Suspected (reasonable possibility) (Suspected (reasonable possibility))
CL Item
Probable (Probable)
Corrective Therapy
Item
Corrective Therapy (If 'YES', Please record on Prior Medication form)
boolean
C0087111 (UMLS CUI [1])
Withdrawal
Item
Was subject withdrawn due to this event?
boolean
C2349954 (UMLS CUI [1])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Afternoon meal
Item
Was afternoon meal/snack eaten before dosing?
boolean
C0439550 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
Date of last food intake
Item
Meal finish date:
date
C0578574 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of last food intake
Item
Time of last food intake
time
C0578574 (UMLS CUI [1])
Date of Dosing
Item
Date of dosing
date
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Dosing
Item
Time of dosing
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Container Number
Item
Please record the following details from the bottle: Container Number
text
C0180098 (UMLS CUI [1])
Label
Item
Please remove the label from the medication carton and attach below:
text
C0013191 (UMLS CUI [1])
Dose Level
Item
Dose Level
text
C0178602 (UMLS CUI [1])
Doctor's Name
Item
Dose checked and administered by:
text
C0027365 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Item Group
Vital Signs Instructions: For each set, semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measurements will be taken after the patients has been erect for a period of 1 min. - The blood pressure cuff must be placed on same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Study Time: Repeat at:
text
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Study time
Code List
Study Time: Repeat at:
CL Item
+ 0.5 hrs (+ 0.5 hrs)
CL Item
+ 1 hrs (+ 1 hrs)
CL Item
+ 1.5 hrs (+ 1.5 hrs)
CL Item
+ 2 hrs (+ 2 hrs)
CL Item
+ 3 hrs (+ 3 hrs)
CL Item
+ 4 hrs (+ 4 hrs)
CL Item
+ 5 hrs (+ 5 hrs)
CL Item
+ 6 hrs (+ 6 hrs)
Date of Examination: Post-Dose
Item
Date
date
C2826643 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Time of Examination: Post-Dose
Item
Time
time
C0040223 (UMLS CUI [1,1])
C0043299 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Semi-supine Systolic Blood Pressure: Post-Dose
Item
Semi-supine Blood Pressure: Systolic
float
C0522019 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Semi-supine Diastolic Blood Pressure: Post-Dose
Item
Semi-supine Blood Pressure: Diastolic
float
C0522019 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Semi-supine Heart Rate: Post-Dose
Item
Semi-supine Heart Rate
float
C0522019 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Erect Systolic Blood Pressure: Post-Dose
Item
Erect Blood Pressure: Systolic
float
C0522014 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Erect Diastolic Blood Pressure: Post-Dose
Item
Erect Blood Pressure: Diastolic
boolean
C0522014 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Erect Heart Rate: Post-Dose
Item
Erect Heart Rate
float
C0522014 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Item Group
Adverse Event - Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient "How are you feeling" (pre-dose) and at subsequent schedules intervals post-dose: "Since you were last asked have you felt unwell or different from usual?" Provide the diagnosis NOT symptoms where possible.
C0877248 (UMLS CUI-1)
Item
Time Point: Repeat at:
text
Time Point
Code List
Time Point: Repeat at:
CL Item
+ 2 hrs (+ 2 hrs)
CL Item
+ 6 hrs (+ 6 hrs)
CL Item
Next Day (by telephone) (Next Day (by telephone))
Adverse Event
Item
Any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
Item Group
Study Protocol
C2348563 (UMLS CUI-1)
Item
In the Investigator's opinion, is it safe for the patient to continue dosing at home?
text
Study Protocol
Code List
In the Investigator's opinion, is it safe for the patient to continue dosing at home?
CL Item
Yes (Y)
CL Item
No (N)
Item
If 'No', select a dosing strategy from options below and tick the relevant box:
text
Dosing Stategy
Code List
If 'No', select a dosing strategy from options below and tick the relevant box:
CL Item
TRY AGAIN (TRY AGAIN)
CL Item
MTD DETERMINED (MTD DETERMINED)
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