Demog: Usubjid, Patient Id, Age, Sex, Race, Screening Weight, Screening Height, BMI etc

Adverse Events: Protocol no, Investigator no, Patient Id, PREFERRED Term, Investigator Term, (Abdominal dis, Freq urination, headache, dizziness, hand-food syndrome, rash, Leukopenia, Neutropenia) Severity, Seriousness (y/n), Seriousness Type (death, life threatening, permanently disabling), Visit number, Start time, Stop time, Related to study drug?

Vitals: Subject number, Study date, Procedure time, Sitting blood pressure, Sitting Cardiac Rate, Visit number, Change from baseline, Dose of treatment at time of vital sign, Abnormal (yes/no), BMI, Systolic blood pressure, Diastolic blood pressure.

ECG: Subject no, Study Date, Study Time, Visit no, PR interval (msec), QRS duration (msec), QT interval (msec), QTc interval (msec), Ventricular Rate (bpm), Change from baseline, Abnormal.

Labs: Subject no, Study day, Lab parameter (Lparm), lab units, ULN (upper limit of normal), LLN (lower limit of normal), visit number, change from baseline, Greater than ULN (yes/no), lab related serious adverse event (yes/no).Medical History: Medical Condition, Date of Diagnosis (yes/no), Years of onset or occurrence, Past condition (yes/no), CURRENT condition (yes/no).

PhysicalExam: Subject no, Exam date, Exam time, Visit number, Reason for exam, Body system, Abnormal (yes/no), Findings, Change from baseline (improvement, worsening, no change), Comments.

Demog: Usubjid, Patient Id, Age, Sex, Race, Screening Weight, Screening Height, BMI etc

Adverse Events: Protocol no, Investigator no, Patient Id, Preferred Term, Investigator Term, (Abdominal dis, Freq urination, headache, dizziness, hand-food syndrome, rash, Leukopenia, Neutropenia) Severity, Seriousness (y/n), Seriousness Type (death, life threatening, permanently disabling), Visit number, Start time, Stop time, Related to study drug?

Vitals: Subject number, Study date, Procedure time, Sitting blood pressure, Sitting Cardiac Rate, Visit number, Change from baseline, Dose of treatment at time of vital sign, Abnormal (yes/no), BMI, Systolic blood pressure, Diastolic blood pressure.

ECG: Subject no, Study Date, Study Time, Visit no, PR interval (msec), QRS duration (msec), QT interval (msec), QTc interval (msec), Ventricular Rate (bpm), Change from baseline, Abnormal.

Labs: Subject no, Study day, Lab parameter (Lparm), lab units, ULN (upper limit of normal), LLN (lower limit of normal), visit number, change from baseline, Greater than ULN (yes/no), lab related serious adverse event (yes/no).Medical History: Medical Condition, Date of Diagnosis (yes/no), Years of onset or occurrence, Past condition (yes/no), Current condition (yes/no).

PhysicalExam: Subject no, Exam date, Exam time, Visit number, Reason for exam, Body system, Abnormal (yes/no), Findings, Change from baseline (improvement, worsening, no change), Comments.