Adverse Event Number
Item
Initial AE Form Number:
float
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Adverse Event Diagnosis
Item
Adverse Event (Diagnosis) (Specify, in the Diagnosis either OVERDOSE INTENTIONAL or OVERDOSE ACCIDENTAL)
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Date
Item
Date of Occurence
date
C0011008 (UMLS CUI [1])
Visit Number
Item
Visit Number
float
C1549755 (UMLS CUI [1])
Overdose: Reason
Item
Relationship: Is there reasonable possibiliy that the overdose was caused by the study treatment?
boolean
C4018909 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Action Taken with Cabazitaxel
Item
Action Taken with CABAZITAXEL
text
C2826626 (UMLS CUI [1,1])
C2830183 (UMLS CUI [1,2])
Overdose: Stop Date
Item
Overdose Stop Date
date
C4018909 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Overdose Seriousness Criteria
Item
Seriousness Criteria
boolean
C0871902 (UMLS CUI [1,1])
C4018909 (UMLS CUI [1,2])
Overdose: Date of Seriousness
Item
If YES: - Date event became serious:
date
C0871902 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C4018909 (UMLS CUI [1,3])
Item
If YES: - Complete this section (Tick all criteria that apply):
text
C0871902 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C4018909 (UMLS CUI [1,3])
Code List
If YES: - Complete this section (Tick all criteria that apply):
CL Item
Congenital anomaly/birth defect (Congenital anomaly/birth defect)
CL Item
Life threatening (Life threatening)
CL Item
Other medically important event (Other medically important event)
CL Item
Persistent/significant disablity/incapacity (Persistent/significant disablity/incapacity)
CL Item
Requiring/prolonging hospitalization (Requiring/prolonging hospitalization)
CL Item
Resulting in death (Resulting in death)
Overdose: Symptomatic
Item
Is the Overdose Symptomatic?
boolean
C4018909 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Overdose: Cabazitaxel
Item
Did the patient overdose with CABAZITAXEL:
boolean
C4018909 (UMLS CUI [1,1])
C2830183 (UMLS CUI [1,2])
Overdose: Medication
Item
Did the patient overdose with OTHER MEDICATION(S)?
boolean
C4018909 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Overdose: Medication Specificiation
Item
If YES, specify below the Name and Dosing and please complete also the corresponding eCRF:
text
C4018909 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Overdose: Substance
Item
Did the patient Overdose with Other Non Medicamentous Substance(s)?
boolean
C4018909 (UMLS CUI [1,1])
C0439861 (UMLS CUI [1,2])
Overdose: Substance Specification
Item
If YES, sepcify the Name and Dosing:
text
C4018909 (UMLS CUI [1,1])
C0439861 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
If the Overdose is intentional, specify
text
C4018909 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
Code List
If the Overdose is intentional, specify
CL Item
With Suicidal Thoughts (With Suicidal Thoughts)
CL Item
Without Suicidal Thoughts (Without Suicidal Thoughts)
Item
Measures taken (Tick all that apply)
text
C4018909 (UMLS CUI [1,1])
C0079809 (UMLS CUI [1,2])
Code List
Measures taken (Tick all that apply)
CL Item
Activated Charcoal (Activated Charcoal)
CL Item
Gastric Lavage/ Induced Vomiting (Gastric Lavage/ Induced Vomiting)
CL Item
Intubation/ Ventilation (Intubation/ Ventilation)
CL Item
Systemic Corrective Therapy* (Systemic Corrective Therapy*)
Overdose: Measures Specification
Item
If OTHER, specify:
text
C4018909 (UMLS CUI [1,1])
C0079809 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Weight
Item
1. Demographics Information Weight
float
Adverse Event: Description
Item
2. Detailed Description of the Adverse Event (including complementary investigations) (Please start the description from the top row of the box in which a maximum of 800 characters is allowed. Please tab to continue entry after a warning beep for each set of 200 characters, displayed in two rows after a tab.)
text
C0678257 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
First Date of Administration of Study Treatment
Item
3. Investigational Products Date of FIRST administration of study treatment:
date
C0805838 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Date of Last Administration: Prednisone
Item
3. Investigational Products Date of LAST administration before SAE Prednisone/ Prednisolone
date
C1762893 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0032952 (UMLS CUI [1,3])
Last Intended Dose: Prednisone
Item
3. Investigational Products Last Intended Dosage before SAE: Prednisone/ Prednisolone
float
C1517741 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0032952 (UMLS CUI [1,4])
Last Actual Dose: Prednisone
Item
3. Investigational Products Last Actual Dosage before SAE: Prednisone/ Prednisolone
float
C1517741 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0032952 (UMLS CUI [1,3])
Date of Last Administration: Cabazitaxel
Item
3. Investigational Products Date of LAST administration before SAE Cabazitaxel
date
C1762893 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C2830183 (UMLS CUI [1,3])
Last Intended Dose: Cabazitaxel
Item
3. Investigational Products Last Intended Dosage before SAE: Cabazitaxel
float
C1517741 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C2830183 (UMLS CUI [1,4])
Last Actual Dose: Cabazitaxel
Item
3. Investigational Products Last Actual Dosage before SAE: Cabazitaxel
float
C1517741 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C2830183 (UMLS CUI [1,3])
Date of Admission
Item
4. In case of hospitalization Date of admission (hospital report to be sent)
date
C1302393 (UMLS CUI [1])
Autopsy Report
Item
5. In case of death Autopsy report (copy to be sent)
boolean
C1548372 (UMLS CUI [1])
Corrective Treatment
Item
6. Corrective Treatment/ Therapy
text
C0719519 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])