ID

34989

Description

Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of his form is to document if the subject has had any adverse events in the course of the study. It should be filled out at the date of vaccination. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1

Link

https://clinicaltrials.gov/ct2/show/NCT00321373

Keywords

Versions (6)
  1. 2/4/19 2/4/19 -
  2. 2/7/19 2/7/19 -
  3. 2/10/19 2/10/19 -
  4. 2/12/19 2/12/19 -
  5. 2/16/19 2/16/19 -
  6. 2/20/19 2/20/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

February 7, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373

English

Solicited Adverse Events

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Solicited Adverse Events
Description

Solicited Adverse Events

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Description

If any of these adverse events meets the protocol definition of serious, please complete a Serious Adverse Event report and fax to GSK Biologicals Study Contact for SAE reporting within 24 hours. If "yes" is ticked, please tick No/Yes for each symptom. If Yes is ticked, please complete all items.

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0877248
Solicited Adverse Events Record - Local Symptoms
Description

Solicited Adverse Events Record - Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
Redness
Description

Redness

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Swelling
Description

Swelling

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Ecchymosis
Description

Ecchymosis

Data type

boolean

Alias
UMLS CUI [1]
C0013491
Pain
Description

Pain

Data type

boolean

Alias
UMLS CUI [1]
C0030193
Day 0
Description

Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked

Data type

integer

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C2826182
Day 1
Description

Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked

Data type

integer

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C2826182
Day 2
Description

Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked

Data type

integer

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C2826182
Day 3
Description

Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked

Data type

integer

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C2826182
Day 4
Description

Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked

Data type

integer

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C2826182
Day 5
Description

Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked

Data type

integer

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C2826182
Day 6
Description

Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked

Data type

integer

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C2826182
Ongoing after Day 6?
Description

Ongoing Symptom

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of Last Day of Symptoms
Description

if ongoing after Day 6

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Solicited Adverse Events - General Symptoms
Description

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Has the subject experienced any of the following signs/symptoms during the solicited period?
Description

If yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items.

Data type

text

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0877248
Solicited Adverse Events Record - General Symptoms
Description

Solicited Adverse Events Record - General Symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Fatigue
Description

Fatigue

Data type

boolean

Alias
UMLS CUI [1]
C0015672
Headache
Description

Headache

Data type

boolean

Alias
UMLS CUI [1]
C0018681
Muscle Ache
Description

Muscle Ache

Data type

boolean

Alias
UMLS CUI [1]
C0231528
Shivering
Description

Shivering

Data type

boolean

Alias
UMLS CUI [1]
C0036973
Arthralgie
Description

Arthralgie

Data type

boolean

Alias
UMLS CUI [1]
C0003862
Day 0
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 1
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 2
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 3
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 4
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 5
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 6
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Ongoing after Day 6?
Description

Ongoing Symptom

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of Last Day of Symptoms
Description

Date of Last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Causality?
Description

Causality

Data type

boolean

Alias
UMLS CUI [1]
C0015127
Solicited Adverse Events - Fever
Description

Solicited Adverse Events - Fever

Fever
Description

Fever: Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Fever Measurement Route
Description

If fever is ticked oral is preferred

Data type

text

Alias
UMLS CUI [1,1]
C0449687
UMLS CUI [1,2]
C0015967
Day 0
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
°C
Day 1
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
°C
Day 2
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
°C
Day 3
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
°C
Day 4
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
°C
Day 5
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
°C
Day 6
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
°C
Day 0 not taken
Description

Day 0 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0437722
UMLS CUI [1,2]
C2826182
Day 1 not taken
Description

Day 1 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0437722
UMLS CUI [1,2]
C2826182
Day 2 not taken
Description

Day 2 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0437722
UMLS CUI [1,2]
C2826182
Day 3 not taken
Description

Day 3 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0437722
UMLS CUI [1,2]
C2826182
Day 4 not taken
Description

Day 4 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0437722
UMLS CUI [1,2]
C2826182
Day 5 not taken
Description

Day 5 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0437722
UMLS CUI [1,2]
C2826182
Day 6 not taken
Description

Day 6 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0437722
UMLS CUI [1,2]
C2826182
Ongoing after Day 6?
Description

Ongoing Symptom

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of Last Day of Symptoms
Description

Date of Last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Causality?
Description

Causality

Data type

boolean

Alias
UMLS CUI [1]
C0015127
Unsolicited Adverse Events
Description

Unsolicited Adverse Events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events from Visit 1 to Visit 2?
Description

If yes, Fill in the Non-Serious Adverse Event section or Serious Adverse Event report, as appropriate.

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0042196
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Similar models

Solicited Adverse Events

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Solicited Adverse Events
C1457887 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C1457887 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Solicited Adverse Events
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Solicited Adverse Events Record - Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Ecchymosis
Item
Ecchymosis
boolean
C0013491 (UMLS CUI [1])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1])
Day 0
Item
Day 0
integer
C0456389 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
Day 1
Item
Day 1
integer
C0456389 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
Day 2
Item
Day 2
integer
C0456389 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
Day 3
Item
Day 3
integer
C0456389 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
Day 4
Item
Day 4
integer
C0456389 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
Day 5
Item
Day 5
integer
C0456389 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
Day 6
Item
Day 6
integer
C0456389 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
Ongoing Symptom
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of Last Day of Symptoms
Item
Date of Last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Solicited Adverse Events - General Symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C0159028 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Solicited Adverse Events - General Symptoms
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Solicited Adverse Events Record - General Symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Fatigue
Item
Fatigue
boolean
C0015672 (UMLS CUI [1])
Headache
Item
Headache
boolean
C0018681 (UMLS CUI [1])
Muscle Ache
Item
Muscle Ache
boolean
C0231528 (UMLS CUI [1])
Shivering
Item
Shivering
boolean
C0036973 (UMLS CUI [1])
Arthralgie
Item
Arthralgie
boolean
C0003862 (UMLS CUI [1])
Item
Day 0
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 0
Code List
Day 0
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Day 1
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 1
Code List
Day 1
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Day 2
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 2
Code List
Day 2
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Day 3
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 3
Code List
Day 3
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Day 4
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 4
Code List
Day 4
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Day 5
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 5
Code List
Day 5
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Day 6
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 6
Code List
Day 6
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Ongoing Symptom
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of Last Day of Symptoms
Item
Date of Last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
Item Group
Solicited Adverse Events - Fever
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Item
Fever Measurement Route
text
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fever Measurement Route
Code List
Fever Measurement Route
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Day 0
Item
Day 0
float
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 1
Item
Day 1
float
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 2
Item
Day 2
float
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 3
Item
Day 3
float
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 4
Item
Day 4
float
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 5
Item
Day 5
float
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 6
Item
Day 6
float
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 0 not taken
Item
Day 0 not taken
boolean
C0437722 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 1 not taken
Item
Day 1 not taken
boolean
C0437722 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 2 not taken
Item
Day 2 not taken
boolean
C0437722 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 3 not taken
Item
Day 3 not taken
boolean
C0437722 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 4 not taken
Item
Day 4 not taken
boolean
C0437722 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 5 not taken
Item
Day 5 not taken
boolean
C0437722 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 6 not taken
Item
Day 6 not taken
boolean
C0437722 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Ongoing Symptom
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of Last Day of Symptoms
Item
Date of Last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events from Visit 1 to Visit 2?
text
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Unsolicited Adverse Events
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events from Visit 1 to Visit 2?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
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