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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    1. 1.2. Medical History
    1. 1.3. Physical Examination
    1. 1.4. Assessment Score
    1. 1.5. Apparative Diagnostics
    1. 1.6. Laboratory
    1. 1.7. Pathology/Histology
    1. 1.8. Consent
    1. 1.9. Therapy
    1. 1.10. Operative Report
    1. 1.11. Adverse Event
    1. 1.12. Follow-Up
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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Breast Cancer NCT00601900 Toxicity - CALGB 40503 Supplemental Adverse Event (AE) Form - 2823361v1.0 - CALGB 40503 Supplemental Adverse Event (AE) Form

- 1/8/15 - 1 form, 3 itemgroups, 24 items, 1 language
Itemgroups: Header Module, Header, ADVERSE EVENTS
CALGB 40503 Supplemental Adverse Event (AE) Form Tamoxifen or Letrozole With or Without Bevacizumab in Treating Women With Stage III or Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=604DB84A-54BF-38D2-E040-BB89AD43495E

Breast Cancer NCT01275677 On-Study - NSABP-B-47 Cardiac Report Form (Form CR) - 3162764v1.0 - Cardiac Report Form Breast Cancer (NCT01275677)

- 1/8/15 - 1 form, 5 itemgroups, 14 items, 1 language
Itemgroups: Header Module, Treatment Status of Patient at Onset of Cardiac Event, Section 1 - Symptoms suggestive of congestive heart failure, even if CHF was not subsequently confirmed, Section 2 - Definite or probable cardiac death, Footer Module
NSABP-B-47 Cardiac Report Form (Form CR) A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women With Node- Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer NCT01275677 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=95D01C7E-6AB6-38AE-E040-BB89AD4351B3

SIOP CNS GCT II SAE DRKS00003907 - SAE

- 9/19/14 - 1 form, 2 itemgroups, 4 items, 2 languages
Itemgroups: Show identification of patient, SAE
SIOP CNS GCT II: Prospective Trial for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Intracranial Germ Cell Tumors. Principal Investigator Gabriele Calaminus, MD. http://clinicaltrials.gov/show/NCT01424839

SIOP CNS GCT II Peri- or postoperative complications DRKS00003907 - Peri- or postoperative complications

- 9/19/14 - 1 form, 5 itemgroups, 18 items, 2 languages
Itemgroups: Show identification of patient, Peri-/postoperative complications, Peri-/postoperative infection, Reoperation, Status of patient
SIOP CNS GCT II: Prospective Trial for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Intracranial Germ Cell Tumors. Principal Investigator Gabriele Calaminus, MD. http://clinicaltrials.gov/show/NCT01424839

SIOP CNS GCT II Event date DRKS00003907 - Event date

- 9/19/14 - 1 form, 1 itemgroup, 2 items, 2 languages
Itemgroup: Event date
SIOP CNS GCT II: Prospective Trial for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Intracranial Germ Cell Tumors. Principal Investigator Gabriele Calaminus, MD. http://clinicaltrials.gov/show/NCT01424839

EWOG SAA Severe complications after day 100 - Severe complications after day 100

- 8/6/14 - 1 form, 11 itemgroups, 24 items, 2 languages
Itemgroups: Show identification of patient, Severe infection occurred, Severe pulmonary complications, Severe cardio-vascular complications, Severe renal complications, Severe hepatic complications, Severe neurological complications, Severe gastrointestinal complications, Severe endocrinologic complications, Severe sceletal complications, Other severe complications
Genetische und immunologische Charakterisierung der schweren aplastischen Anaemie (SAA) bei Kindern und Jugendlichen (EWOG-SAA) http://ewog-mds.org/

EWOG SAA Severe complications after day 100 - Severe complications after day 100

- 8/6/14 - 1 form, 10 itemgroups, 22 items, 2 languages
Itemgroups: Show identification of patient, Severe infection occurred, Severe pulmonary complications, Severe cardio-vascular complications, Severe renal complications, Severe hepatic complications, Severe neurological complications, Severe gastrointestinal complications, Severe endocrinologic complications, Severe sceletal complications
Genetische und immunologische Charakterisierung der schweren aplastischen Anaemie (SAA) bei Kindern und Jugendlichen (EWOG-SAA) http://ewog-mds.org/

EWOG SAA Severe complications till day +100 - Severe complications till day +100

- 8/6/14 - 1 form, 10 itemgroups, 20 items, 2 languages
Itemgroups: Show identification of patient, Severe infection occurred, Severe pulmonary complications, Severe cardio-vascular complications, Severe renal complications, Severe hepatic complications, VOD, Severe neurological complications, Severe gastrointestinal complications, Other severe complications
Genetische und immunologische Charakterisierung der schweren aplastischen Anaemie (SAA) bei Kindern und Jugendlichen (EWOG-SAA) http://ewog-mds.org/

EWOG MDS 2006 Severe complications after day 100 DRKS00003789 - Severe complications after day 100

- 8/5/14 - 1 form, 11 itemgroups, 24 items, 2 languages
Itemgroups: Show identification of patient, Severe infection occurred, Severe pulmonary complications, Severe cardio-vascular complications, Severe renal complications, Severe hepatic complications, Severe neurological complications, Severe gastrointestinal complications, Severe endocrinologic complications, Severe sceletal complications, Other severe complications
Prospective non–randomized multi​center study for epidemiology and characterization of Myelodysplastic Syndromes(MDS) and Juvenile Myelomonocytic Leukemia (JMML) in child­hood. PI: Prof. Dr. Charlotte Niemeyer http://clinicaltrials.gov/ct2/show/NCT00662090 http://www.ewog-mds.org/

EWOG MDS 2006 Severe complications till day +100 DRKS00003789 - Severe complications till day +100

- 8/5/14 - 1 form, 10 itemgroups, 20 items, 2 languages
Itemgroups: Show identification of patient, Severe infection occurred, Severe pulmonary complications, Severe cardio-vascular complications, Severe renal complications, Severe hepatic complications, VOD, Severe neurological complications, Severe gastrointestinal complications, Other severe complications
Prospective non–randomized multi​center study for epidemiology and characterization of Myelodysplastic Syndromes(MDS) and Juvenile Myelomonocytic Leukemia (JMML) in child­hood. PI: Prof. Dr. Charlotte Niemeyer http://clinicaltrials.gov/ct2/show/NCT00662090 http://www.ewog-mds.org/

Ewing Study SAE DRKS00003588 - SAE

- 8/4/14 - 1 form, 2 itemgroups, 4 items, 2 languages
Itemgroups: Show identification of patient, SAE
EWING 2008, EudraCT 2008-003658-13, http://clinicaltrials.gov/ct2/show/NCT00824083

Ewing Study Event date DRKS00003588 - Event date

- 8/4/14 - 1 form, 1 itemgroup, 2 items, 2 languages
Itemgroup: Event date
EWING 2008, EudraCT 2008-003658-13, http://clinicaltrials.gov/ct2/show/NCT00824083

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