ID

25697

Beschrijving

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 7 (Day 36)

Trefwoorden

Versies (1)
  1. 11-09-17 11-09-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

11 september 2017

DOI

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Licentie

Creative Commons BY-NC-ND 3.0
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Dose Level 7 GSK Ropinirole Restless Legs Syndrome 101468

Engels

Dose Level 7 GSK Ropinirole Restless Legs Syndrome 101468

1 Formulieren  
Patient Information
Beschrijving

Patient Information

Alias
UMLS CUI-1
C1955348
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C1830427
Centre Number
Beschrijving

Centre Number

Datatype

text

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

Visit Day

Datatype

date

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

Predose Checklist - Instructions: Please mark appropriate answer 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 refrained from consuming alcohol from midnight prior to the clinic visit?
Beschrijving

Last Alcohol Consumption

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C1517741
2. Has the patient limited their daily alcohol 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.)
Beschrijving

Alcohol consumption

Datatype

boolean

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

Strenuous Exercise

Datatype

boolean

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

Smoking Status

Datatype

boolean

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

Caffeinated beverage

Datatype

boolean

Alias
UMLS CUI [1]
C0678438
6. 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.
Beschrijving

OTC or herbal remedies

Datatype

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0025125
7. 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)
Beschrijving

Concomitant Medication

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
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.
Beschrijving

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
Beschrijving

Date of Examination: Pre-Dose

Datatype

date

Maateenheden
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2826643
UMLS CUI [1,2]
C0439565
dd-mmm-yyyy
Time
Beschrijving

Time of Examination: Pre-Dose

Datatype

time

Maateenheden
  • 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
Beschrijving

Semi-supine Systolic Blood Pressure: Pre-Dose

Datatype

float

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

Semi-supine Diastolic Blood Pressure: Pre-Dose

Datatype

float

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0428883
UMLS CUI [1,3]
C0439565
mmHg
Semi-supine Heart Rate
Beschrijving

Semi-supine Heart Rate: Pre-Dose

Datatype

float

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C0439565
bpm
Erect Blood Pressure: Systolic
Beschrijving

Erect Systolic Blood Pressure: Pre-Dose

Datatype

float

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0871470
UMLS CUI [1,3]
C0439565
mmHg
Erect Blood Pressure: Diastolic
Beschrijving

Erect Diastolic Blood Pressure: Pre-Dose

Datatype

float

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0428883
UMLS CUI [1,3]
C0439565
mmHg
Erect Heart Rate
Beschrijving

Erect Heart Rate: Pre-Dose

Datatype

float

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0018810
bpm
Dosing Details
Beschrijving

Dosing Details

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

Afternoon meal

Datatype

boolean

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

Date of last food intake

Datatype

date

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

Time of last food intake

Datatype

time

Maateenheden
  • 24hr:min
Alias
UMLS CUI [1]
C0578574
24hr:min
Date of dosing
Beschrijving

Date of Dosing

Datatype

date

Maateenheden
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
dd-mmm-yyyy
Time of dosing
Beschrijving

Time of Dosing

Datatype

time

Maateenheden
  • 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
Beschrijving

Container Number

Datatype

text

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

Label

Datatype

text

Alias
UMLS CUI [1]
C0013191
Dose Level
Beschrijving

Dose Level

Datatype

text

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

Doctor's Name

Datatype

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.
Beschrijving

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:
Beschrijving

Study time: Post-Dose

Datatype

text

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

Date of Examination: Post-Dose

Datatype

date

Maateenheden
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2826643
UMLS CUI [1,2]
C0439568
dd-mmm-yyyy
Time
Beschrijving

Time of Examination: Post-Dose

Datatype

time

Maateenheden
  • 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
Beschrijving

Semi-supine Systolic Blood Pressure: Post-Dose

Datatype

float

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

Semi-supine Diastolic Blood Pressure: Post-Dose

Datatype

float

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0428883
UMLS CUI [1,3]
C0439568
mmHg
Semi-supine Heart Rate
Beschrijving

Semi-supine Heart Rate: Post-Dose

Datatype

float

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C0439568
bpm
Erect Blood Pressure: Systolic
Beschrijving

Repeat the erect measurements IMMEDIATELY if reading is technically invalid & discard inaccurate data, enter the repeat data in the CRF.

Datatype

float

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0871470
UMLS CUI [1,3]
C0439568
mmHg
Erect Blood Pressure: Diastolic
Beschrijving

Repeat the erect measurements IMMEDIATELY if reading is technically invalid & discard inaccurate data, enter the repeat data in the CRF.

Datatype

boolean

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

Repeat the erect measurements IMMEDIATELY if reading is technically invalid & discard inaccurate data, enter the repeat data in the CRF.

Datatype

float

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C0439568
bpm
Alert Criteria (readings of potential clinical concern): Recording either a fall in systolic blood pressure of >30 mmHg or diastolic of 20 mmHg from semi-supine to an erect position, or a decrease of > 30 mmHg for systolic pressure or 20 mmHg for diastolic pressure from corresponding mean measurement taken at pre-dose. OR The patient reports orthostatic symptoms such as feeling faint of dizzy that fulfill criteria common toxicity grade (CTC) grade 2 or greater for hypotension
Beschrijving

Alert Criteria

Datatype

text

Alias
UMLS CUI [1,1]
C3665546
UMLS CUI [1,2]
C0243161
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.
Beschrijving

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:
Beschrijving

Time Point

Datatype

text

Any Adverse Events?
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Study Protocol
Beschrijving

Study Protocol

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

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.

Datatype

text

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

TRY AGAIN - Patient will receive the next days dose in the clinic. Complete an Extra Clinic Visit section of the CRF for this visit. DOSE REDUCTION = Ensure patient returns home with medication for the previous for the previous dose level and diary card. Schedule another clinic visit for a 2nd attempt at up titration (3 - 7 days later). Complete an Extra Clinic Visit section of the CRF for this visit. Complete study medication section below. 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.

Datatype

text

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Similar models

Dose Level 7 GSK Ropinirole Restless Legs Syndrome 101468

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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 appropriate answer 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)
Last Alcohol Consumption
Item
1. 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
2. Has the patient limited their daily alcohol 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
3. 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
4. Has the patient maintained their normal smoking practice?
boolean
C1519386 (UMLS CUI [1])
Caffeinated beverage
Item
5. 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
6. 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
7. 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
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
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])
Alert Criteria
Item
Alert Criteria (readings of potential clinical concern): Recording either a fall in systolic blood pressure of >30 mmHg or diastolic of 20 mmHg from semi-supine to an erect position, or a decrease of > 30 mmHg for systolic pressure or 20 mmHg for diastolic pressure from corresponding mean measurement taken at pre-dose. OR The patient reports orthostatic symptoms such as feeling faint of dizzy that fulfill criteria common toxicity grade (CTC) grade 2 or greater for hypotension
text
C3665546 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
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)
CL Item
DOSE REDUCTION (DOSE REDUCTION)
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