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- 15-03-21 - 1 Formulier, 24 Itemgroepen, 129 Data-elementen, 2 Talen
Itemgroepen: Header, Eligibility Question, Demography, Physical examination, Disease Characteristics, Metastatic Disease Site, local laboratory, Residual toxicities related to previous therapy for cancer, Residual toxicities, Cancer related current medical conditions, Medical Conditions, non-cancer related medical conditions, Medical Conditions, Prior anti-cancer therapy, Prior anti-cancer therapy - medication, Prior anti-cancer therapy - radiotherapy, Vital signs, ECOG Performance Status Scale, 12 LEAD ECG, 12-lead ECG Abnormalities, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, Electronically transferred laboratory data
- 03-06-18 - 1 Formulier, 24 Itemgroepen, 95 Data-elementen, 1 Taal
Itemgroepen: Header, investigational product discontinuation, PGx-Pharmacogenetic Research, Concomitant Medications, If Yes to Concominant Medication, Non-serious adverse events, Non-serious adverse events, Serious adverse event, Serious adverse events description, Seriousness, Document section Demography data, SECTION 4, Section 5, Relevant Medical Conditions, Document section Risk factors, Document section Concomitant Medications, Drug Details, Assessments, Document section, Pregnancy information, Death, Study Conclusion, Investigator comment log, Investigators Signature
- 15-05-18 - 1 Formulier, 15 Itemgroepen, 64 Data-elementen, 1 Taal
Itemgroepen: Header, Vital signs, ECOG Performance Status, Electronically transferred lab data - CA-125, Physical examination, Concomitant Medication, Adverse Events, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, Pharmacokinetics Blood, Investigational Product, Biomarker sample(s), investigational product, Treatment Confirmation

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