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Table 1 Schedule of activities for phase ib to evaluate safety and MTD in gastrointestinal tumors and acute leukemias

From: Exploring the safety and efficacy of phytomedicine Petiveria alliacea extract (Esperanza) in patients with metastatic gastrointestinal tumors and acute leukemias: study protocol for a phase Ib/randomized double blind phase II trial (PA001)

Schedule of activities

 

Enrollment

Initial Visit and chemotherapy cycle 1

Cycle 2

Close-out

Time point

Week 1

Week 2

Week 6

Week 7

Enrolment

 Screening and Informed Consent

X

   

 Physical Examen

 

X

X

X

 Clinical Record

 

X

X

X

 HIV Test and Pregnancy test

X

   

Interventions

 Medication dispensing

 

X

X

X

 Follow-up visit

 

X

X

X

Safety Assessment

 Hemogram

 

X

X

X

 Transaminase AST

 

X

X

X

 Transaminase ALT

 

X

X

X

 Alkaline Phosphatase

 

X

X

X

 Total Bilirubin

 

X

X

X

 Triglycerides

 

X

X

X

 Total Cholesterol

 

X

X

X

 Blood Urea Nitrogen (BUN)

 

X

X

X

 Creatinine

 

X

X

X

 Urinalysis

 

X

X

X

 Uric Acid

 

X

X

X

 LDH (Lactate Dehydrogenase)

 

X

X

X

 Lactic Acid

 

X

X

X

 Ferritin

 

X

X

X

 Albumin

 

X

X

X

 Iron

 

X

X

X

 Electrocardiogram

 

X

X

X

 Echocardiogram