ID

35466

Description

Safety and Efficacy Study of mFOLFOX6 + Panitumumab Combination Therapy and 5-FU/LV + Panitumumab Combination Therapy in Patients With Chemotherapy-naïve Unresectable Advanced Recurrent Colorectal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02337946

Link

https://clinicaltrials.gov/show/NCT02337946

Keywords

  1. 3/5/19 3/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 5, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Colorectal Carcinoma NCT02337946

Eligibility Colorectal Carcinoma NCT02337946

Criteria
Description

Criteria

1. patients with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer)
Description

Adenocarcinoma of large intestine unresectable | Carcinoma of the Appendix Excluded | Carcinoma of anal canal Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C1319315
UMLS CUI [1,2]
C1519810
UMLS CUI [2,1]
C0728951
UMLS CUI [2,2]
C0332196
UMLS CUI [3,1]
C0563211
UMLS CUI [3,2]
C0332196
2. patients with measurable lesion(s) according to the recist ver. 1.1
Description

Measurable lesion

Data type

boolean

Alias
UMLS CUI [1]
C1513041
3. patients who have not received chemotherapy for colorectal cancer. patients who experience relapse more than 6 months after the final dose of perioperative adjuvant chemotherapy with fluoropyrimidine agents may be enrolled.
Description

Chemotherapy Absent Colorectal Carcinoma | Recurrent disease | Status post Adjuvant Chemotherapy perioperative | fluoropyrimidine

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0009402
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0085533
UMLS CUI [3,3]
C1518988
UMLS CUI [4]
C0596581
4. aged ≥ 20 years at the time of informed consent
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. patients classified as kras wild-type. however, the criteria will be changed to all patients who are verified to be of kras and nras wild-type when the kras and nras tests come to be covered by national health insurance, and the tests become feasible at medical institutions.
Description

Patients KRAS Wild Type | Patients NRAS Wild Type

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1537502
UMLS CUI [1,3]
C1883559
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0809246
UMLS CUI [2,3]
C1883559
6. patients who satisfy the following criteria for the major organ function in tests performed within 14 days prior to enrollment 1) neutrophil count ≥ 1.5 × 103/μl 2) white blood cell count ≥ 3.0 × 103/μl 3) platelet count ≥ 10.0 × 104/μl 4) hemoglobin
Description

Organ Major function | Neutrophil count | White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0031843
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0518015
≥ 9.0 g/dl 5) total bilirubin ≤ 2.0 mg/dl 6) ast ≤ 100 u/l (≤ 200 u/l if liver metastases are present) 7) alt ≤ 100 u/l (≤ 200 u/l if liver metastases are present) 8) serum creatinine ≤ 1.5 mg/dl
Description

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver | Alanine aminotransferase measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0494165
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201976
7. patients who are assessed at eastern cooperative oncology group (ecog) performance status (p.s.) of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
8. life expectancy of ≥ 6 months after enrollment
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
9. patients who have given written consent to take part in the study after detailed explanation of the study prior to enrollment
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
inclusion criteria for randomization:
Description

Inclusion criteria Randomization

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0034656
1. patients who have received 6 cycles of mfolfox6 + panitumumab combination therapy
Description

Combined Modality Therapy Course Quantity | FOLFOX-6 Regimen modified | panitumumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1880660
UMLS CUI [2,2]
C0392747
UMLS CUI [3]
C0879427
2. patients who are assessed at ecog p.s. of 0-1 in the 6th cycle.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
3. patients for whom pd or not evaluable has been denied on the recist based on imaging tests conducted after the day of administration in the 6th cycle within 14 days (2 weeks).
Description

Progressive Disease Absent Diagnostic Imaging | Evaluable Disease Diagnostic Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0011923
UMLS CUI [2,1]
C1516986
UMLS CUI [2,2]
C0011923
exclusion criteria for enrollment:
Description

Exclusion Criteria Enrollment

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1516879
1. radiotherapy received for a measurable lesion
Description

Therapeutic radiology procedure Measurable lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1513041
2. radiotherapy received within 28 days (4 weeks) prior to enrollment for a lesion other than measurable lesions
Description

Therapeutic radiology procedure Lesion | Exception Measurable lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0221198
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1513041
3. known brain metastasis or strongly suspected of brain metastasis
Description

Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Strong Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0442821
UMLS CUI [2,3]
C0750491
4. synchronous cancers or metachronous cancers with a disease-free period of ≤ 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection (esophageal, stomach, and cervical cancer, non-melanoma skin cancer, bladder cancer, etc.).
Description

Malignant Neoplasms Synchronous | Metachronous Malignant Neoplasm | Period Disease Free | Exception Colorectal Carcinoma | Exception Malignant Neoplasm Mucous Membrane Cured | Exception Malignant Neoplasm Mucous Membrane Resected | Exception Esophageal carcinoma | Exception Stomach Carcinoma | Exception Cervical cancer | Exception Skin carcinoma | Exception Carcinoma of bladder

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0439580
UMLS CUI [2]
C1334703
UMLS CUI [3,1]
C1948053
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0009402
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C0026724
UMLS CUI [5,4]
C1880198
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0006826
UMLS CUI [6,3]
C0026724
UMLS CUI [6,4]
C1521996
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0152018
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0699791
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C4048328
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0699893
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0699885
5. body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.)
Description

Body cavity fluid Treatment required for | Pleural effusion | Ascites | Pericardial effusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0333343
UMLS CUI [1,2]
C0005889
UMLS CUI [1,3]
C0332121
UMLS CUI [2]
C1253943
UMLS CUI [3]
C0003962
UMLS CUI [4]
C0031039
6. patients who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy
Description

Contraceptive methods Unwilling | Pregnancy | Breast Feeding | Pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0240802
7. active hemorrhage requiring blood transfusion
Description

Hemorrhage Requirement Blood Transfusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0005841
8. disease requiring systemic steroids for treatment (excluding topical steroids)
Description

Disease Requirement Systemic steroids | Topical steroids Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C2825233
UMLS CUI [2,1]
C2064827
UMLS CUI [2,2]
C0332196
9. intestinal resection and colostomy within 2 weeks prior to enrollment
Description

Intestinal resection | Colostomy

Data type

boolean

Alias
UMLS CUI [1]
C1096244
UMLS CUI [2]
C0009410
10. history or obvious and extensive ct findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.)
Description

Lung Disease, Interstitial | Interstitial Lung Disease CT | Pneumonia, Interstitial | Pulmonary Fibrosis

Data type

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2,1]
C0206062
UMLS CUI [2,2]
C0040405
UMLS CUI [3]
C0206061
UMLS CUI [4]
C0034069
11. serious drug hypersensitivity
Description

Drug Allergy Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0205404
12. local or systemic active infection requiring treatment, or fever indicating infection
Description

Local infection Treatment required for | Sepsis Treatment required for | Fever | Communicable Disease Indicated

Data type

boolean

Alias
UMLS CUI [1,1]
C1400591
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0243026
UMLS CUI [2,2]
C0332121
UMLS CUI [3]
C0015967
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C1444656
13. intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhea (incapacitating symptoms despite adequate treatment)
Description

Paralytic Ileus | Gastrointestinal obstruction | Diarrhea Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0030446
UMLS CUI [2]
C0236124
UMLS CUI [3,1]
C0011991
UMLS CUI [3,2]
C0205318
14. active hepatitis b and/or active hepatitis c
Description

Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
15. known human immunodeficiency virus infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
16. other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study
Description

Study Subject Participation Status Ineligible

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
exclusion criteria for randomization:
Description

Exclusion Criteria Randomization

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0034656
1. patients in whom interstitial pneumonia has been newly diagnosed during the period from registration to randomization
Description

Pneumonia, Interstitial

Data type

boolean

Alias
UMLS CUI [1]
C0206061
2. patients who have received radiotherapy during the period from registration to randomization
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
3. other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study
Description

Study Subject Participation Status Ineligible

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714

Similar models

Eligibility Colorectal Carcinoma NCT02337946

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adenocarcinoma of large intestine unresectable | Carcinoma of the Appendix Excluded | Carcinoma of anal canal Excluded
Item
1. patients with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer)
boolean
C1319315 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0728951 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0563211 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Measurable lesion
Item
2. patients with measurable lesion(s) according to the recist ver. 1.1
boolean
C1513041 (UMLS CUI [1])
Chemotherapy Absent Colorectal Carcinoma | Recurrent disease | Status post Adjuvant Chemotherapy perioperative | fluoropyrimidine
Item
3. patients who have not received chemotherapy for colorectal cancer. patients who experience relapse more than 6 months after the final dose of perioperative adjuvant chemotherapy with fluoropyrimidine agents may be enrolled.
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0009402 (UMLS CUI [1,3])
C0277556 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0085533 (UMLS CUI [3,2])
C1518988 (UMLS CUI [3,3])
C0596581 (UMLS CUI [4])
Age
Item
4. aged ≥ 20 years at the time of informed consent
boolean
C0001779 (UMLS CUI [1])
Patients KRAS Wild Type | Patients NRAS Wild Type
Item
5. patients classified as kras wild-type. however, the criteria will be changed to all patients who are verified to be of kras and nras wild-type when the kras and nras tests come to be covered by national health insurance, and the tests become feasible at medical institutions.
boolean
C0030705 (UMLS CUI [1,1])
C1537502 (UMLS CUI [1,2])
C1883559 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0809246 (UMLS CUI [2,2])
C1883559 (UMLS CUI [2,3])
Organ Major function | Neutrophil count | White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement
Item
6. patients who satisfy the following criteria for the major organ function in tests performed within 14 days prior to enrollment 1) neutrophil count ≥ 1.5 × 103/μl 2) white blood cell count ≥ 3.0 × 103/μl 3) platelet count ≥ 10.0 × 104/μl 4) hemoglobin
boolean
C0178784 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
C0200633 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver | Alanine aminotransferase measurement | Creatinine measurement, serum
Item
≥ 9.0 g/dl 5) total bilirubin ≤ 2.0 mg/dl 6) ast ≤ 100 u/l (≤ 200 u/l if liver metastases are present) 7) alt ≤ 100 u/l (≤ 200 u/l if liver metastases are present) 8) serum creatinine ≤ 1.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
ECOG performance status
Item
7. patients who are assessed at eastern cooperative oncology group (ecog) performance status (p.s.) of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
8. life expectancy of ≥ 6 months after enrollment
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
9. patients who have given written consent to take part in the study after detailed explanation of the study prior to enrollment
boolean
C0021430 (UMLS CUI [1])
Inclusion criteria Randomization
Item
inclusion criteria for randomization:
boolean
C1512693 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Combined Modality Therapy Course Quantity | FOLFOX-6 Regimen modified | panitumumab
Item
1. patients who have received 6 cycles of mfolfox6 + panitumumab combination therapy
boolean
C0009429 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1880660 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0879427 (UMLS CUI [3])
ECOG performance status
Item
2. patients who are assessed at ecog p.s. of 0-1 in the 6th cycle.
boolean
C1520224 (UMLS CUI [1])
Progressive Disease Absent Diagnostic Imaging | Evaluable Disease Diagnostic Imaging
Item
3. patients for whom pd or not evaluable has been denied on the recist based on imaging tests conducted after the day of administration in the 6th cycle within 14 days (2 weeks).
boolean
C1335499 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C1516986 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
Exclusion Criteria Enrollment
Item
exclusion criteria for enrollment:
boolean
C0680251 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
Therapeutic radiology procedure Measurable lesion
Item
1. radiotherapy received for a measurable lesion
boolean
C1522449 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
Therapeutic radiology procedure Lesion | Exception Measurable lesion
Item
2. radiotherapy received within 28 days (4 weeks) prior to enrollment for a lesion other than measurable lesions
boolean
C1522449 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1513041 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Strong Suspected
Item
3. known brain metastasis or strongly suspected of brain metastasis
boolean
C0220650 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
Malignant Neoplasms Synchronous | Metachronous Malignant Neoplasm | Period Disease Free | Exception Colorectal Carcinoma | Exception Malignant Neoplasm Mucous Membrane Cured | Exception Malignant Neoplasm Mucous Membrane Resected | Exception Esophageal carcinoma | Exception Stomach Carcinoma | Exception Cervical cancer | Exception Skin carcinoma | Exception Carcinoma of bladder
Item
4. synchronous cancers or metachronous cancers with a disease-free period of ≤ 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection (esophageal, stomach, and cervical cancer, non-melanoma skin cancer, bladder cancer, etc.).
boolean
C0006826 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
C1334703 (UMLS CUI [2])
C1948053 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0009402 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C0026724 (UMLS CUI [5,3])
C1880198 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C0026724 (UMLS CUI [6,3])
C1521996 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C0152018 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0699791 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C4048328 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C0699893 (UMLS CUI [10,2])
C1705847 (UMLS CUI [11,1])
C0699885 (UMLS CUI [11,2])
Body cavity fluid Treatment required for | Pleural effusion | Ascites | Pericardial effusion
Item
5. body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.)
boolean
C0333343 (UMLS CUI [1,1])
C0005889 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C1253943 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0031039 (UMLS CUI [4])
Contraceptive methods Unwilling | Pregnancy | Breast Feeding | Pregnancy test positive
Item
6. patients who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0240802 (UMLS CUI [4])
Hemorrhage Requirement Blood Transfusion
Item
7. active hemorrhage requiring blood transfusion
boolean
C0019080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0005841 (UMLS CUI [1,3])
Disease Requirement Systemic steroids | Topical steroids Excluded
Item
8. disease requiring systemic steroids for treatment (excluding topical steroids)
boolean
C0012634 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C2825233 (UMLS CUI [1,3])
C2064827 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Intestinal resection | Colostomy
Item
9. intestinal resection and colostomy within 2 weeks prior to enrollment
boolean
C1096244 (UMLS CUI [1])
C0009410 (UMLS CUI [2])
Lung Disease, Interstitial | Interstitial Lung Disease CT | Pneumonia, Interstitial | Pulmonary Fibrosis
Item
10. history or obvious and extensive ct findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.)
boolean
C0206062 (UMLS CUI [1])
C0206062 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0206061 (UMLS CUI [3])
C0034069 (UMLS CUI [4])
Drug Allergy Serious
Item
11. serious drug hypersensitivity
boolean
C0013182 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Local infection Treatment required for | Sepsis Treatment required for | Fever | Communicable Disease Indicated
Item
12. local or systemic active infection requiring treatment, or fever indicating infection
boolean
C1400591 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0243026 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0015967 (UMLS CUI [3])
C0009450 (UMLS CUI [4,1])
C1444656 (UMLS CUI [4,2])
Paralytic Ileus | Gastrointestinal obstruction | Diarrhea Uncontrolled
Item
13. intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhea (incapacitating symptoms despite adequate treatment)
boolean
C0030446 (UMLS CUI [1])
C0236124 (UMLS CUI [2])
C0011991 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Hepatitis B | Hepatitis C
Item
14. active hepatitis b and/or active hepatitis c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
HIV Infection
Item
15. known human immunodeficiency virus infection
boolean
C0019693 (UMLS CUI [1])
Study Subject Participation Status Ineligible
Item
16. other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
Exclusion Criteria Randomization
Item
exclusion criteria for randomization:
boolean
C0680251 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Pneumonia, Interstitial
Item
1. patients in whom interstitial pneumonia has been newly diagnosed during the period from registration to randomization
boolean
C0206061 (UMLS CUI [1])
Therapeutic radiology procedure
Item
2. patients who have received radiotherapy during the period from registration to randomization
boolean
C1522449 (UMLS CUI [1])
Study Subject Participation Status Ineligible
Item
3. other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])

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