1.1
Description *(diagnosis (if known) or signs/symptoms)*
1.2
Start date
1.3
Ongoing at end of study
1.4
End date
Only shown if field 1.3 is equal to 2
**NOTE: End date adverse event is before start date adverse event. Please adjust!**
Only shown if field 1.30 is equal to 1
1.6
Intensity
1.7
Relation with study medication
1.8
Action study medication
1.9
Specify other study medication action
Only shown if field 1.8 is equal to 6
1.10
Other action *(check all that apply)*
1.11
Specify other other action
Only shown if field 1.10 is equal to 4
1.12
Is the Adverse Event reduced after discontinuation of the study medication or adjustment of the dose?
1.13
Is the study medication re-administered or is the adjusted dose returned to the original dosage?
Only shown if field 1.12 is equal to 1
1.14
Date of administration/dose return to original dosage
Only shown if field 1.13 is equal to 1
1.15
Did the Adverse Event recur after restarting the study medication or after the adjusted dose was returned to the original dosage?
Only shown if field 1.13 is equal to 1
1.16
Date Adverse Event recurred
Only shown if field 1.15 is equal to 1
1.17
Outcome
1.18
If stabilized, stabilization date
Only shown if field 1.17 is equal to 2
1.19
Specify residual symptoms
Only shown if field 1.17 is equal to 4
1.20
Date of death
Only shown if field 1.17 is equal to 5
1.21
Serious Adverse Event?
1.22
(check 1 or more answer options)
Only shown if field 1.21 is equal to 1
1.23
Admission date
Only shown if field 1.22 is equal to 3
1.24
Discharge date
Only shown if field 1.22 is equal to 3
**NOTE: Hospital discharge date is before hospital admission date. Please adjust!**
Only shown if field 1.31 is equal to 1
1.26
Specify other event
Only shown if field 1.22 is equal to 6
**Note: "Hospitalisation" is not checked for Other action AND for Specification SAE**
Only shown if field 1.32 is equal to 0
1.28
Expected?
**Potential SUSAR.** See "https://english.ccmo.nl/investigators/clinical-trials-with-medicinal-products-ctr/conduct-of-study-ctr/safety-reporting/serious-adverse-events-and-susars" for more information on reporting a SUSAR
Only shown if field 1.33 is equal to 1
1.30
Is stop datum vóór start datum adverse event?
1.31
Is ontslag datum vóór opname datum?
1.32
Cross check 'ziekenhuisopname' Overig vs SAE
1.33
SUSAR check
2.1
Description *(diagnosis (if known) or signs/symptoms)*
2.2
Start date
2.3
Ongoing at end of study
2.4
End date
Only shown if field 2.3 is equal to 2
**NOTE: End date adverse event is before start date adverse event. Please adjust!**
Only shown if field 2.28 is equal to 1
2.6
Intensity
2.7
Relation with study intervention
2.8
Action study treatment
2.9
Specify modified action
Only shown if field 2.8 is equal to 4
2.10
Other action *(check all that apply)*
2.11
Specify other other action
Only shown if field 2.10 is equal to 4
2.12
Is the Adverse Event reduced after discontinuation or modification of study treatment?
2.13
Is the study treatment resumed or is the adjusted study treatment returned to the original study treatment?
Only shown if field 2.12 is equal to 1
2.14
Date of resumption/reduction of study treatment
Only shown if field 2.13 is equal to 1
2.15
Did the Adverse Event recur after restarting study treatment or after the modified study treatment was returned to the original study treatment?
Only shown if field 2.13 is equal to 1
2.16
Date Adverse Event reccurred
Only shown if field 2.15 is equal to 1
2.17
Outcome
2.18
If stabilized, date of stabilization
Only shown if field 2.17 is equal to 2
2.19
Specify residual symptoms
Only shown if field 2.17 is equal to 4
2.20
Date of death
Only shown if field 2.17 is equal to 5
2.21
Serious Adverse Event?
2.22
(check 1 or more answer options)
Only shown if field 2.21 is equal to 1
2.23
Admission date
Only shown if field 2.22 is equal to 3
2.24
Discharge date
Only shown if field 2.22 is equal to 3
NOTE: Discharge date of hospitalisation is before admission date of hospitalisation. Please adjust!
Only shown if field 2.29 is equal to 1
2.26
Specify other event
Only shown if field 2.22 is equal to 6
NOTE: "Hospitalisation"; is not checked for Other action AND for Specification SAE
Only shown if field 2.30 is equal to 0
2.28
Is stop datum vóór start datum?
2.29
Is opname datum vóór ontslag datum?
2.30
Cross check 'ziekenhuisopname' Overig vs SAE
3.1
Description *(diagnosis (if known) or signs/symptoms)*
3.2
Start date
3.3
Ongoing at end of study
3.4
End date
Only shown if field 3.3 is equal to 2
**NOTE: End date adverse event is before start date adverse event. Please adjust!**
Only shown if field 3.30 is equal to 1
3.6
Intensity
3.7
Relation with study medication
3.8
Action medical device
3.9
Specify other action medical device
Only shown if field 3.8 is equal to 6
3.10
Other action *(check all that apply)*
3.11
Specify other other action
Only shown if field 3.10 is equal to 4
3.12
Is the Adverse Event reduced after discontinuation of the study medication or adjustment of the dose?
3.13
Is the study medication re-administered or is the adjusted dose returned to the original dosage?
Only shown if field 3.12 is equal to 1
3.14
Date of administration/dose returned to original dosage
Only shown if field 3.13 is equal to 1
3.15
Did the Adverse Event recur after restarting the medical device or after the adjusted dose was returned to the original dosage?
Only shown if field 3.13 is equal to 1
3.16
Date Adverse Event recurred
Only shown if field 3.15 is equal to 1
3.17
Outcome
3.18
If stabilized, stabilization date
Only shown if field 3.17 is equal to 2
3.19
Specify residual symptoms
Only shown if field 3.17 is equal to 4
3.20
Date of death
Only shown if field 3.17 is equal to 5
3.21
Serious Adverse Event?
3.22
(check 1 or more answer options)
Only shown if field 3.21 is equal to 1
3.23
Admission date
Only shown if field 3.22 is equal to 3
3.24
Discharge date
Only shown if field 3.22 is equal to 3
NOTE: Discharge date of hospitalisation is before admission date of hospitalisation. Please adjust!
Only shown if field 3.31 is equal to 1
3.26
Specify other event
Only shown if field 3.22 is equal to 6
**NOTE: "Hospitalisation" is not checked for Other action AND for Specification SAE**
Only shown if field 3.32 is equal to 0
3.28
Expected?
**Potential USADE.** See "https://www.ccmo.nl/onderzoekers/publicaties/publicaties/2021/05/08/flowchart-ongewenste-voorvallen-onderzoek-met-medische-hulpmiddelen" for more information on reporting a USADE
Only shown if field 3.33 is equal to 1
3.30
Is stop datum vóór start datum adverse event?
3.31
Is ontslag datum vóór opname datum?
3.32
Cross check 'ziekenhuisopname' Overig vs SAE
3.33
USADE check
YesNo
1: Yes
2: No
Intensity AE
1: Mild
2: Moderate
3: Severe
Relation AE
1: Related
2: Not related
Action AE
1: None
2: Temporary stop
3: Permanent stop
4: Dose reduced
5: Dose increased
6: Other
-1: Unknown
-2: Not applicable _(treatment period with study medication already ended or participant deceased)_
Other action AE
1: None
2: Comedication: _complete on medication page_
3: (prolongation of) hospitalisation
4: Other
-1: Unknown
-2: Not applicable _(participant deceased)_
YesNoNa
1: Yes
2: No
-2: Not applicable
YesNoUnk
1: Yes
2: No
-1: Unknown
Outome AE
1: Recovered
2: Not recovered
3: Recovering
4: Recovered with sequelae
5: Fatal
-1: Unknown
-2: Not applicable
Spec SAE
1: Results in death
2: Life threatening
3: (prolongation of) hospitalisation
4: Persistent or significant disability/incapacity for work
5: Congenital abnormality/birth defect
6: Other event of medical importance
Action - ND
1: None
2: Temporary stop
3: Permanent stop
4: Modified
-1: Unknown
-2: Not applicable _(study treatment period already ended or participant deceased)_