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ID
29207
Beschreibung
A Phase IIa prospective, open-label, multicenter study to determine the pharmacokinetics (PK) and safety and tolerability of aztreonam-avibactam (ATM-AVI) for the treatment of complicated Intra-Abdominal Infections (cIAIs) in hospitalized adults. NCT02655419 Sponsors and Collaborators: Pfizer Innovative Medicines Initiative (IMI) COMBACTE-CARE Investigators: Study Director:Pfizer CT.gov Call Center;Pfizer Principal Investigator:Oliver Cornely;Clinical Trials Centre Cologne
Stichworte
Versionen (2)
- 07.03.18 07.03.18 -
- 17.09.21 17.09.21 -
Rechteinhaber
Pfizer
Hochgeladen am
7. März 2018
DOI
10.21961/mdm:29207
Lizenz
Creative Commons BY-NC 3.0
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REJUVENATE NCT02655419
Treatment 1-3 Visit 3-5
Ähnliche Modelle
Treatment 1-3 Visit 3-5
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Patient Caption
Item
Patient Caption
text
C2825231 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,2])
Visit Number
Item
Visit Number
integer
C1549755 (UMLS CUI [1])
Trial name
Item
Trial name
text
C1629065 (UMLS CUI [1])
Visit Name
Item
Visit Name
text
C2826704 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Study site
Item
Site Name
text
C2825164 (UMLS CUI [1])
Item Group
Infection-related Examination
C3714514 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0031809 (UMLS CUI-2)
Examination performed
Item
Examination performed
boolean
C0031809 (UMLS CUI [1])
Not done reason
Item
if 'no', provide reason
text
C2826287 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Infection related Signs and Symptoms
C0037088 (UMLS CUI-1)
C3714514 (UMLS CUI-2)
C3714514 (UMLS CUI-2)
CL Item
Other,specify (10)
CL Item
Chills and rigors (9)
CL Item
Ascites (8)
CL Item
Abdominal mass (7)
CL Item
Abdominal guarding (6)
CL Item
Rebound tenderness (5)
CL Item
Tenderness to palpation (4)
CL Item
Vomiting (3)
CL Item
Nausea (2)
CL Item
Abdominal Pain (1)
Other Sign or Symptom
Item
Please specify Other Sign or Symptom
text
C0037088 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
CL Item
Not Assessed (99)
CL Item
Severe (3)
CL Item
Moderate (2)
CL Item
Mild (1)
CL Item
Absent (0)
Item Group
Post-Operative Wound Examination
C2112579 (UMLS CUI-1)
C0886052 (UMLS CUI-2)
C0886052 (UMLS CUI-2)
Examination performed
Item
Examination performed
boolean
C0582103 (UMLS CUI [1,1])
C0886052 (UMLS CUI [1,2])
C0886052 (UMLS CUI [1,2])
Not done reason
Item
if 'no', provide reason
text
C2826287 (UMLS CUI [1])
Superficial Infection
Item
Does the Patient have a Superficial Infection?
boolean
C0043241 (UMLS CUI [1,1])
C0205124 (UMLS CUI [1,2])
C0205124 (UMLS CUI [1,2])
Deep Wound Infection
Item
Does the Patient have a Deep Wound Infection?
boolean
C0406103 (UMLS CUI [1])
CL Item
Surgical Incision Site (1)
CL Item
Laparoscopic Incision Site (2)
CL Item
Percutaneous Drainage Site (3)
CL Item
Other (99)
other Wound Type
Item
Kind of other Wound Type
text
C1276783 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Negative Pressure Wound Device
Item
Negative Pressure Wound Device present?
boolean
C1956078 (UMLS CUI [1])
Specimen for Culture
Item
Specimen for Culture obtained?
boolean
C0430402 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,2])
Item Group
Signs and Symptoms of Wound Infection
C0037088 (UMLS CUI-1)
C0043241 (UMLS CUI-2)
C0043241 (UMLS CUI-2)
CL Item
Erythema (1)
CL Item
Induration (2)
CL Item
Tenderness (3)
CL Item
Warmth (4)
CL Item
Fluctuation (5)
CL Item
Swelling (6)
CL Item
Wound Pain (7)
CL Item
Dehiscence (8)
CL Item
Purulent Discharge (9)
CL Item
Non Purulent Discharge (10)
CL Item
Other (11)
Other infection sign
Item
Please specify Other Sign or Symptom
text
C0037088 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
CL Item
Not Assessed (99)
CL Item
Severe (3)
CL Item
Moderate (2)
CL Item
Mild (1)
CL Item
Absent (0)
comment
Item
If not assessed, please provide a comment
text
C0947611 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Vital Signs examination
C0518766 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0031809 (UMLS CUI-2)
Examination performed
Item
Examination performed
boolean
C0031809 (UMLS CUI [1])
Not done reason
Item
if 'no', provide reason
text
C2826287 (UMLS CUI [1])
Supine Blood Pressure Systolic
Item
Supine Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Relevance
Item
Clinically relevant?
boolean
C2347946 (UMLS CUI [1])
Supine Blood Pressure Diastolic
Item
Supine Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Relevance
Item
Clinically relevant?
boolean
C2347946 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Relevance
Item
Clinically relevant?
boolean
C2347946 (UMLS CUI [1])
Respiratory Rate
Item
Respiratory Rate
integer
C0231832 (UMLS CUI [1])
Relevance
Item
Clinically relevant?
boolean
C2347946 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Time of measurement
Item
Time of measurement
time
C0242485 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item
Method of Measurement
integer
C1299991 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,2])
CL Item
Other (99)
(Comment:en)
CL Item
Tympanic (4)
(Comment:en)
CL Item
Rectal (3)
(Comment:en)
CL Item
Axillary (2)
(Comment:en)
CL Item
Oral (1)
(Comment:en)
Other Method
Item
Kind of Other Method
text
C1299991 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Relevance
Item
Clinically relevant?
boolean
C2347946 (UMLS CUI [1])
Temperature measurement
Item
Result of measurement
float
C0005903 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Item Group
Study drug loading dose
C0304229 (UMLS CUI-1)
C3714444 (UMLS CUI-2)
C3714444 (UMLS CUI-2)
Start Date of ATM-AVI
Item
Start Date of ATM-AVI
date
C0004521 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
End Date of ATM-AVI
Item
End Date of ATM-AVI
date
C0004521 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C0806020 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
End time of ATM-AVI
Item
End time of ATM-AVI
time
C0004521 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C1522314 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Infusion Rate (mL/min)
Item
Infusion Rate (mL/min)
integer
C2964135 (UMLS CUI [1])
Item
Route of Study Drug Administration
integer
C0013153 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
CL Item
Monoluminal Central Line (1)
(Comment:en)
CL Item
Biluminal Central Line (2)
(Comment:en)
CL Item
Triluminal Central Line (3)
(Comment:en)
CL Item
Multiluminal Central Line (4)
(Comment:en)
CL Item
PICC Line (5)
(Comment:en)
CL Item
Peripheral IV Catheter left (6)
(Comment:en)
CL Item
Peripheral IV Catheter right (7)
(Comment:en)
CL Item
Other (99)
(Comment:en)
Comment on Administration
Item
Comment on Administration
text
C0947611 (UMLS CUI [1])
Item Group
Study drug administration ATM-AVI
C0304229 (UMLS CUI-1)
C3469597 (UMLS CUI-2)
C0004521 (UMLS CUI-3)
C3489748 (UMLS CUI-4)
C3469597 (UMLS CUI-2)
C0004521 (UMLS CUI-3)
C3489748 (UMLS CUI-4)
Infusion out of range referring to loading dose
Item
Infusion out of range referring to loading dose
text
C3845292 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0205543 (UMLS CUI [1,3])
C3714444 (UMLS CUI [1,4])
C0574032 (UMLS CUI [1,2])
C0205543 (UMLS CUI [1,3])
C3714444 (UMLS CUI [1,4])
Start Date of ATM-AVI
Item
Start Date of ATM-AVI
date
C0004521 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
Start time of ATM-AVI
Item
Start time of ATM-AVI
time
C0004521 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C1301880 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
End Date of ATM-AVI
Item
End Date of ATM-AVI
date
C0004521 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C0806020 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
End time of ATM-AVI
Item
End time of ATM-AVI
time
C0004521 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C1522314 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
ATM Dose (mg) to be given per protocol
Item
ATM Dose (mg) to be given per protocol
integer
C0040808 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0004521 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0004521 (UMLS CUI [1,3])
AVI Dose (mg) to be given per protocol
Item
AVI Dose (mg) to be given per protocol
integer
C0040808 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C3489748 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C3489748 (UMLS CUI [1,3])
ATM Batch No.
Item
ATM Batch No.
text
C0004521 (UMLS CUI [1,1])
C3641829 (UMLS CUI [1,2])
C3641829 (UMLS CUI [1,2])
AVI Batch No.
Item
AVI Batch No.
text
C3489748 (UMLS CUI [1,1])
C3641829 (UMLS CUI [1,2])
C3641829 (UMLS CUI [1,2])
Start Volume
Item
StartVol Bag (mL)
integer
C0574032 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
C2700258 (UMLS CUI [1,2])
End Volume
Item
EndVol Bag (mL)
integer
C0574032 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
C2700258 (UMLS CUI [1,2])
Infusion Rate (mL/min)
Item
Infusion Rate (mL/min)
integer
C2964135 (UMLS CUI [1])
Item
Route of Study Drug Administration
integer
C0013153 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
CL Item
Monoluminal Central Line (1)
(Comment:en)
CL Item
Biluminal Central Line (2)
(Comment:en)
CL Item
Triluminal Central Line (3)
(Comment:en)
CL Item
Multiluminal Central Line (4)
(Comment:en)
CL Item
PICC Line (5)
(Comment:en)
CL Item
Peripheral IV Catheter left (6)
(Comment:en)
CL Item
Peripheral IV Catheter right (7)
(Comment:en)
CL Item
Other (99)
(Comment:en)
Comment on Administration
Item
Comment on Administration
text
C0947611 (UMLS CUI [1])
Item Group
Study drug administration Metronidazole
C0304229 (UMLS CUI-1)
C3469597 (UMLS CUI-2)
C0025872 (UMLS CUI-3)
C3469597 (UMLS CUI-2)
C0025872 (UMLS CUI-3)
Infusion out of range referring to loading dose
Item
Infusion out of range referring to loading dose
text
C3845292 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0205543 (UMLS CUI [1,3])
C3714444 (UMLS CUI [1,4])
C0574032 (UMLS CUI [1,2])
C0205543 (UMLS CUI [1,3])
C3714444 (UMLS CUI [1,4])
Start Date of Metronidazole
Item
Start Date of Metronidazole
date
C0025872 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Start time of Metronidazole
Item
Start time of Metronidazole
time
C0025872 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
End Date of Metronidazole
Item
End Date of Metronidazole
date
C0025872 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
End time of Metronidazole
Item
End time of Metronidazole
time
C0025872 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Metronidazole Dose (mg) to be given per protocol
Item
Metronidazole Dose (mg) to be given per protocol
integer
C0040808 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0025872 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0025872 (UMLS CUI [1,3])
Metronidazole Batch No.
Item
Metronidazole Batch No.
text
C0025872 (UMLS CUI [1,1])
C3641829 (UMLS CUI [1,2])
C3641829 (UMLS CUI [1,2])
Start Volume
Item
StartVol Bag (mL)
integer
C0574032 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
C2700258 (UMLS CUI [1,2])
End Volume
Item
EndVol Bag (mL)
integer
C0574032 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
C2700258 (UMLS CUI [1,2])
Infusion Rate (mL/min)
Item
Infusion Rate (mL/min)
integer
C2964135 (UMLS CUI [1])
Comment on Administration
Item
Comment on Administration
text
C0947611 (UMLS CUI [1])
Surgery performed
Item
Surgery performed
boolean
C0543467 (UMLS CUI [1])
Item
Kind of Surgical Procedure
integer
C0683312 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,2])
CL Item
Initial Procedure (1)
CL Item
Reintervention (2)
CL Item
Laparotomy (1)
CL Item
Percutaneous Draingae of Abscess (2)
CL Item
Laparoscopy (3)
CL Item
Wound Debridement without Laparotomy (4)
CL Item
Other (99)
Other procedure
Item
Other procedure
text
C0543467 (UMLS CUI [1])
Start Date (incision)
Item
Start Date (incision)
date
C0808070 (UMLS CUI [1,1])
C0184898 (UMLS CUI [1,2])
C0184898 (UMLS CUI [1,2])
Start Time (incision)
Item
Start Time (incision)
time
C1301880 (UMLS CUI [1,1])
C0184898 (UMLS CUI [1,2])
C0184898 (UMLS CUI [1,2])
End Date (suture)
Item
End Date (suture)
date
C0806020 (UMLS CUI [1,1])
C0038969 (UMLS CUI [1,2])
C0038969 (UMLS CUI [1,2])
End Time (suture)
Item
End Time (suture)
time
C1522314 (UMLS CUI [1,1])
C0038969 (UMLS CUI [1,2])
C0038969 (UMLS CUI [1,2])
CL Item
Persistent or recurrent infection in the abdomen (1)
CL Item
Superficial wound infection (2)
CL Item
Deep wound infection (3)
CL Item
Adverse Event (4)
CL Item
Other (99)
Other reason
Item
Other reason
text
C3840932 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Description of Findings
C0678257 (UMLS CUI-1)
C0243095 (UMLS CUI-2)
C0243095 (UMLS CUI-2)
Description of Findings during Surgical Procedure
Item
Description of Findings during Surgical Procedure
text
C0543467 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Microbiology specimen collection
Item
Was a specimen collected?
boolean
C0200345 (UMLS CUI [1,1])
C0025952 (UMLS CUI [1,2])
C0025952 (UMLS CUI [1,2])
CL Item
Other (99)
CL Item
Attempt made but unable to obtain/produce sample (1)
inability
Item
Please specify inability
text
C1299582 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
inability
Item
Please specify other reason
text
C1299582 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
Specimen collection date
Item
Date of collection
date
C1302413 (UMLS CUI [1])
Specimen collection time
Item
Time of Collection
time
C4064021 (UMLS CUI [1])
Item
Culture Processing Type
integer
C0200949 (UMLS CUI [1,1])
C0037793 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0037793 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
CL Item
Anaerobic (2)
CL Item
Aerobic (1)
Item
Site of sample
integer
C0200345 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
CL Item
Other (99)
CL Item
Blood (2)
CL Item
Intra-Abdominal (1)
Item
Intra-Abdominal, please specify
integer
C1512910 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
CL Item
Other (99)
CL Item
Surgical Swab (4)
CL Item
Peritoneal Fluid (3)
CL Item
Tissue (2)
CL Item
Pus (1)
Other site, please specify
Item
Other site, please specify
text
C1515974 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])
CL Item
Not done (99)
CL Item
Growth (2)
CL Item
No Growth (1)
Isolate name
Item
Isolate name
text
C1764827 (UMLS CUI [1])
CL Item
Fungal (2)
CL Item
Bacterial (1)
Item
Isolate Classification
integer
C1764827 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,2])
CL Item
Contaminant (2)
CL Item
Pathogen (1)
Disc Zone ATM-AVI
Item
Disc Zone ATM-AVI
text
C1283010 (UMLS CUI [1,1])
C0004521 (UMLS CUI [1,2])
C1283010 (UMLS CUI [2,1])
C3489748 (UMLS CUI [2,2])
C0004521 (UMLS CUI [1,2])
C1283010 (UMLS CUI [2,1])
C3489748 (UMLS CUI [2,2])
Sample sent to Central Lab
Item
Sample sent to Central Lab?
boolean
C1880016 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,3])
C0370003 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,3])
Central Laboratory Accession ID Number
Item
Central Lab Accession ID Number
text
C2826726 (UMLS CUI [1,1])
C1880016 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,2])
Not done reason
Item
If no, reason
text
C2826287 (UMLS CUI [1])
Backup Sample sent to Central Laboratory
Item
Backup Sample sent to Central Lab (if necessary)?
boolean
C0370003 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
Central Laboratory Accession ID Number
Item
New Central Lab Accession ID Number
text
C2826726 (UMLS CUI [1,1])
C1880016 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,2])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Any overdose at this treatment?
Item
Any overdose at this treatment?
boolean
C4018909 (UMLS CUI [1])
Item
Medication overdose
integer
C4018909 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
CL Item
ATM (1)
CL Item
AVI (2)
CL Item
Metronidazole (3)
Overdose
Item
overdose
boolean
C4018909 (UMLS CUI [1])
CL Item
Intravenous (1)
CL Item
Intramuscular (2)
CL Item
Subcutaneous (3)
CL Item
Per Oral (4)
CL Item
Topical (5)
CL Item
Peritoneal Lavage (6)
CL Item
Other (99)
Administration Route
Item
Other Route
text
C0013153 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
integer
C2986497 (UMLS CUI [1])
Unit used
Item
Dose unit
text
C1519795 (UMLS CUI [1])
Date of Overdose
Item
Date of Overdose
date
C0011008 (UMLS CUI [1,1])
C4018909 (UMLS CUI [1,2])
C4018909 (UMLS CUI [1,2])
Intentional overdose
Item
Intentional overdose
boolean
C4018909 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
C1283828 (UMLS CUI [1,2])
Overdose associated with AE
Item
Overdose associated with AE
boolean
C4018909 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
AE-Term
Item
AE-Term
text
C2826934 (UMLS CUI [1])
Reason for Overdose
Item
Reason for Overdose
text
C4018909 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Serum Creatinine (1)
CL Item
AST (GOT) (2)
CL Item
ALT (GPT) (3)
CL Item
ALP (4)
CL Item
Total Bilirubin (5)
CL Item
GGT (6)
CL Item
INR (7)
Specimen collection
Item
Sample collected
boolean
C0200345 (UMLS CUI [1])
CL Item
Insufficient amount collected (1)
CL Item
Hemolyzed sample (2)
CL Item
Unable to obtain venous access (3)
CL Item
Patient not able to provide urine sample (4)
CL Item
Missed sample collection (5)
CL Item
Other (99)
Specify other
Item
Other, please specify
text
C3845569 (UMLS CUI [1])
Laboratory value
Item
Laboratory value
text
C0587081 (UMLS CUI [1])
CL Item
U/L (IU/L) (1)
CL Item
mmol/L (2)
CL Item
μmol/L (3)
CL Item
g/dL (4)
CL Item
mg/dL (5)
CL Item
g/L (6)
CL Item
L/L (7)
CL Item
microKat/L (8)
CL Item
Other (99)
Other lab unit
Item
Other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Clinical significance
Item
Was this value clinically signifcant?
boolean
C2826293 (UMLS CUI [1])
Upper limit of normal
Item
Upper limit of normal
text
C1519815 (UMLS CUI [1])
Increased LAB value
Item
Increased LAB value (3xULN;2xULN)
text
C0587081 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0205217 (UMLS CUI [1,2])
Potential Hy's Law
Item
Potential Hy's Law
boolean
C0860207 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,2])
Notification
Item
Notification Lab Liver
boolean
C0422202 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
Examination performed
Item
Examination performed
boolean
C0022885 (UMLS CUI [1])
Not done reason
Item
if 'no', provide reason
text
C2826287 (UMLS CUI [1])
Collection Date
Item
Collection Date
date
C1302413 (UMLS CUI [1])
Collection time
Item
Collection time
time
C4064021 (UMLS CUI [1])
Creatinine Clearance
Item
Creatinine Clearance
integer
C0373595 (UMLS CUI [1])
Clinical significance
Item
Was this value clinically signifcant?
boolean
C2826293 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Liver Diagnostic Assessments
C0232741 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
Potential Hy's Law Examination
Item
Potential Hy's Law Examination performed
boolean
C0860207 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0332149 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Potential Hy's Law Case Number
Item
Potential Hy's Law Case Number
integer
C0860207 (UMLS CUI [1,1])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
CL Item
Ultrasound (1)
CL Item
CT (2)
CL Item
MRI/MRCP (3)
CL Item
ERCP (4)
CL Item
Liver Biopsy (5)
CL Item
X-Ray (6)
CL Item
Tox Screening for Acetaminophen/Paracetamol (7)
CL Item
Tox Screening for Ethanol (8)
CL Item
Tox Screening, Other (9)
CL Item
Serology for Hepatitis A (10)
CL Item
Serology for Hepatitis B (11)
CL Item
Serology for Hepatitis C (12)
CL Item
Serology for Hepatitis D (13)
CL Item
Serology for Hepatitis E (14)
CL Item
Serology for Cytomegalovirus (15)
CL Item
Serology for Epstein Barr Virus (16)
CL Item
Autoimmune Serology (17)
CL Item
Specialist consulted (18)
CL Item
Other (19)
Examination performed
Item
Assessment performed
boolean
C2985643 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,2])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Liver Diagnostic Result
Item
Liver Diagnostic Result
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
Investigation Specification
Item
Investigation Specification
text
C2348235 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,2])
Potential Hy's Law Case Number
Item
Potential Hy's Law Case Number
integer
C0860207 (UMLS CUI [1,1])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
CL Item
Alcohol abuse (1)
CL Item
Increased Alcohol Consumption (within 1 Month) (2)
CL Item
IV Drug Abuse (3)
CL Item
Tattoo (4)
CL Item
Acupuncture (5)
CL Item
Sexual transmitted diseases (6)
CL Item
Toxic/Chemical Agent Exposure (7)
CL Item
Travel (Areas at Risk within last Year) (8)
CL Item
Pregnancy (9)
CL Item
Parenteral Nutrition (10)
CL Item
Excessive Physical Exercise (11)
CL Item
Changesdiet/Fasting Episodes/Weight Loss Diet (12)
CL Item
Previous Drug Reaction (Elevation of Liver Tests) (13)
CL Item
Blood Transfusion (14)
CL Item
Exposure to Anyone with Jaundince within last Month (15)
CL Item
History of Hypotension (16)
CL Item
Low Blood Pressure/Abnormal Liver Lab Value (17)
CL Item
Other (18)
Occurrence
Item
Occurrence
boolean
C2745955 (UMLS CUI [1])
Risk Factor Details
Item
Risk Factor Details
text
C0035648 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
CL Item
Past (1)
CL Item
Current (2)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Liver signs and symptoms
C0037088 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0023884 (UMLS CUI-2)
Potential Hy's Law Case Number
Item
Potential Hy's Law Case Number
integer
C0860207 (UMLS CUI [1,1])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Item Group
Liver signs and symptoms
C0037088 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0023884 (UMLS CUI-2)
CL Item
Anorexia (1)
CL Item
Abdominal Pain (2)
CL Item
Nausea (3)
CL Item
Vomiting (4)
CL Item
Pruritis (5)
CL Item
Dark Urine (6)
CL Item
Arthralgia (7)
CL Item
Coma (8)
CL Item
Confusional State (9)
CL Item
Rash (10)
CL Item
Purpura (11)
CL Item
Jaundice (12)
CL Item
Mucosa Inflammation (13)
CL Item
Lymphadenopathy (14)
CL Item
Abdominal Tenderness (15)
CL Item
Upper Quadrant Tenderness (16)
CL Item
Hepatomegaly (17)
CL Item
Splenomegaly (18)
CL Item
Ascites (19)
CL Item
Asthenia (20)
CL Item
Pyrexia (21)
CL Item
Biliary Obstruction (22)
CL Item
Eosinophilia (23)
CL Item
Other (24)
Occurrence
Item
Occurrence
boolean
C2745955 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Intermittent
Item
Intermittent
boolean
C0205267 (UMLS CUI [1])
Other Liver Sign or Symptom
Item
Other Liver Sign or Symptom
text
C0037088 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Patient Caption
Item
Patient Caption
text
C2825231 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,2])
Visit Number
Item
Visit Number
integer
C1549755 (UMLS CUI [1])
Trial name
Item
Trial name
text
C1629065 (UMLS CUI [1])
Visit Name
Item
Visit Name
text
C2826704 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Study site
Item
Site Name
text
C2825164 (UMLS CUI [1])
Examination performed
Item
Examination performed
boolean
C2826672 (UMLS CUI [1])
Not done reason
Item
If 'no', please provide reason
text
C2826287 (UMLS CUI [1])
ECG at Day 3
Item
ECG at Day 3
boolean
C1623258 (UMLS CUI [1])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Patient Caption
Item
Patient Caption
text
C2825231 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,2])
Visit Number
Item
Visit Number
integer
C1549755 (UMLS CUI [1])
Trial name
Item
Trial name
text
C1629065 (UMLS CUI [1])
Visit Name
Item
Visit Name
text
C2826704 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Study site
Item
Site Name
text
C2825164 (UMLS CUI [1])
Item Group
PK sample sent to Central Lab
C1880016 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
C1515023 (UMLS CUI-3)
C0370003 (UMLS CUI-2)
C1515023 (UMLS CUI-3)
Item
Which Sample should be collected at Day 4?
integer
C0005834 (UMLS CUI [1,1])
C0086960 (UMLS CUI [1,2])
C0086960 (UMLS CUI [1,2])
CL Item
Intensive sample (1)
CL Item
Sparse Sample (2)
Start Date experimental drug
Item
Start Date of referring Study Drug Infusion
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Start time experimental drug
Item
Start Time of referring Study Drug Infusion
time
C0304229 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
End Date experimental drug
Item
End Date of referring Study Drug Infusion
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
End time experimental drug
Item
End Time of referring Study Drug Infusion
time
C0304229 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Samples sent to Central Lab?
Item
Samples sent to Central Lab?
boolean
C1880016 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,3])
C0370003 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,3])
Not done reason
Item
If 'no', please provide a reason
text
C2826287 (UMLS CUI [1])
comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Item Group
Pharmakokinetics Sampling at Day 4
C0005834 (UMLS CUI-1)
C0031327 (UMLS CUI-2)
C0031327 (UMLS CUI-2)
Item
PK Sampling Day 4:Intensive Sample, Patient 1-25
integer
C0005834 (UMLS CUI [1,1])
C0086960 (UMLS CUI [1,2])
C0086960 (UMLS CUI [1,2])
CL Item
within 10 min prior to start of infusion (1)
CL Item
0,5 h after start of infusion (2)
CL Item
1 h after start of infusion (3)
CL Item
2 h after start of infusion (4)
CL Item
within 15 min. before end of infusion (5)
CL Item
3 h 15 min. after start of infusion (6)
CL Item
3 h 30 min. after start of infusion (7)
CL Item
3 h 45 min. after start of infusion (8)
CL Item
4h after start of infusion (9)
CL Item
5h after start of infusion (10)
CL Item
6h after start of infusion (11)
Specimen Collection
Item
Sample Collected?
boolean
C0200345 (UMLS CUI [1])
CL Item
Sample Acceptable (0)
CL Item
Hemolyzed (1)
CL Item
Clotted (2)
CL Item
Lipemic (3)
CL Item
Quantity Less than Expected (50)
CL Item
Sample Discarded (51)
CL Item
Other (99)
Specimen Condition, Other
Item
Specimen Condition, Other
text
C1547869 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Date of PK collection
Item
Date of PK collection
date
C1317250 (UMLS CUI [1])
Actual Time of PK Collection
Item
Actual Time of PK Collection
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
Item
Site of Collection
integer
C0005834 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
CL Item
Monoluminal Central Line (1)
CL Item
Biluminal Central Line (2)
CL Item
Triluminal Central Line (3)
CL Item
Multiluminal Central Line (4)
CL Item
PICC Line (5)
CL Item
Peripheral IV Catheter left (6)
CL Item
Peripheral IV Catheter right (7)
CL Item
Direct Venipuncture (8)
CL Item
Other (99)
Storing date
Item
Date aliquots stored in freezer
date
C0011008 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,3])
C0370003 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,3])
Storing time
Item
Time aliquots stored in freezer
time
C0040223 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,3])
C0370003 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,3])
Specimen Identifier
Item
PK Specimen Identifier ATM plasma
text
C1299222 (UMLS CUI [1,1])
C0004521 (UMLS CUI [1,2])
C0004521 (UMLS CUI [1,2])
Specimen Identifier
Item
PK Specimen Identifier AVI plasma
text
C1299222 (UMLS CUI [1,1])
C3489748 (UMLS CUI [1,2])
C3489748 (UMLS CUI [1,2])
Backup Identifier
Item
Backup Identifier ATM plasma
text
C1552560 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
C0004521 (UMLS CUI [1,3])
C1299222 (UMLS CUI [1,2])
C0004521 (UMLS CUI [1,3])
Backup Identifier
Item
Backup Identifier AVI plasma
text
C1552560 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
C3489748 (UMLS CUI [1,3])
C1299222 (UMLS CUI [1,2])
C3489748 (UMLS CUI [1,3])
Item
Specimen collection category
integer
C0200345 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,2])
CL Item
PK, Biofluid (5)
CL Item
Not applicable (98)
CL Item
Blood (4)
Item
Biofluid processed
integer
C0370003 (UMLS CUI [1,1])
C1709694 (UMLS CUI [1,2])
C1709694 (UMLS CUI [1,2])
CL Item
Plasma (21)
Item
Main consent category
integer
C0021430 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,2])
CL Item
Main Consent Excluding Genetics (2)