CASE REPORT FORM (CRF) (FRAGMENT)

CLINICAL TRIAL SECTION

Investigative Site ID 659-782-344 Investigative Site Address
4500 San Pablo Road, Jacksonville, FL 32224
Name of Clinical Trial CALM Name of Principal Investigator Jane
Protocol Number 4075 Investigator Brochure Number 3098
Investigative Drug Generic Name Gladmycin Drug Brand Name Happymycin
Dose 2 mcg/kg/min Phase of Study Phase III Method of Study

Way of Administration: Special Instruction V

I.V.
P.O.
I.M.
S.C.
Duration of the treatment in days 30 Frequency of visits Twice per week

PATIENT REGISTRATION SECTION

Patient ID: 0196
Patient First Name Joyce Patient Last Name: Payne
Informed Consent: YES Date of Patient Registration 20 June, 2009
Patient Main Diagnosis Alzheimer’s disease
List of Other Medical Problems Anxiety Indigestion BP
Age 10 years Gender: Male Female Unknown
Weight 49 KG Height 5.3
Vital Signs Before Treatment Start: High BP Pulse Tachycardia Temperature P.O. Normal
Permanent Medications:
Name of Medication Dosage Administration Times a day

CASE MONITORING

VITAL SIGNS AND ADVERSE EVENTS/REACTIONS MONITORING SECTION

 Day of Date of Dose Blood Pulse Temperature Bloo Adverse Reactions
Treatment Visit received Pressure P.O d
Suga
r
102 beats 110 Abdominal pain,
20 2 per mg constipation,
Day 1 June, mcg/kg/min 130/80 minute Normal diminished movement,
09 dizziness, drowsiness,
dry mouth.
21 2 90 beats 110 As above
Day 2 June, mcg/kg/min 130/80 per Normal mg
09 minute
27 2 80 beats 110 As above
Day 3 June, mcg/kg/min 110/80 per Normal mg
09 minute
28 2 80 beats 110 As above
Day 4 June, mcg/kg/min 110/80 per Normal mg
09 minute
01 July, 2 80 beats 110 As above
Day 5 09 mcg/kg/min 110/80 per Normal mg
minute
02 July, 2 80 beats 110 As above
Day 6 09 mcg/kg/min 110/80 per Normal mg
minute
14 July, 2 75 beats 110 As above
Day 7 09 mcg/kg/min 110/75 per Normal mg
minute
15 July, 2 80 beats 110 As above
Day 8 09 mcg/kg/min 110/75 per Normal mg
minute
PATIENT PHYSICAL EXAMINATIONS SECTION

Day of treatment Date of Visit Physical Evaluation

On general inspection, Joyce appeared to be tired. She also had a
few bruises on her left arm, due to frequent cannulation and blood
test, a scar from her recent biopsy on the right side of her forehead.
Day 1 20 June, 09
On cardiovascular, respiratory and abnormal examinations, no
significant signs were detected. Blood pressure was High 130/82.
Pulse rate was 80 ats per minute and respiratory rate was 14 beats
per minute.

Day 2 21 June, 09
PATIENT LABORATORY TESTS MONITORING SECTION

Blood Count Monitoring

Day of Date of WBC (White RCB (Red HGB MCV PLA % % %

treatment Test Blood Cells) Blood (Hemogl (Mean Trombo MONO GRAN RETI
Cells) obin) Corpuscular cytes Monocy Granulo Reticul
Volume) tes cytes ocytes

Biochemistry Blood Tests Monitoring

Day of Date of GLU CRE UREA Na K Cl T.BIL LDH CHOL CPK UR.AC
Treatment Test

Day of Date Volume Uric Leucocytes PH Nitrite Protei Glucose Bilirubin Erithrocytes Ketons
Treatment of Urine acid n
Test

Urine Tests Monitoring

ELECTROCARDIOGRAPHY AND ECHOCARDIOGRAPHY MONITORING SECTION

ELECTROCARDIOGRAPHY

Day of Treatment Date ECG Done Changes in ECG (Electrocardiogram

ECHOCARDIOGRAPHY

Day of Date LAD RVD IVS LVED LVESD LVPW AoRoot E A IVRT
Treatment ECHO D Wave Wave
Done