Patient ID
D04
Serious AE
ALT > 50
AST > 40
Dropout
Center: StJohns
Primary Site of Cancer: Breast
Age: 44

Demographics
Investigator Name
Robert Wollman
Age
44
Height (inches)
69.3
Gender
Female
Race
Hispanic
Center
StJohns
  
Adverse Event Timline *
graphic
* Red: Life-threatening/Severe, Blue: Moderate, Green: Mild, Grey:Missing
  
Adverse Events *
Prefered Term
Category
Start
Stop
Duration
Severity
Relation
Serious
Action Taken
Pruritus/itching
DERMATOLOGY/SKIN
4/2/08
4/25/08
23
Moderate
Possible
No
None
Pulmonary/Upper Respiratory - Other (Specify, Re
PULMONARY/UPPER RESPIRATORY
4/11/08
4/15/08
4
Moderate
Unrelated
No
None
Pain: Extremity Limb
PAIN
4/11/08
 
 
Mild
Unrelated
No
None
Pain: Extremity Limb
PAIN
4/30/08
 
 
Missing
Missing
NA
Missing
* Serious AEs highlighted
  
graphic
Blue: Cold Remedies, Green: Other
  
Concomitant Medications
Medication
Start
Stop
Indication
Dose
Units
Route
Continu-    ing
Ativan
 
2/28/08
anti anxiety
1
TABLETS
 
No
Coumadin
 
2/28/08
anti coagulant
1
TABLETS
 
No
FEC Taxotere
10/25/07
2/14/08
Br. CA
 
 
 
No
EPH 200
2/21/08
3/19/08
diet pill
1
TABLETS
 
No
Udderly Smooth
4/2/08
4/25/08
itching
cream
APPLICATIONS
TOPICAL
No
Cortaid
4/2/08
4/25/08
itching
cream
APPLICATIONS
TOPICAL
No
  
Labs
graphic
graphic
graphic
graphic
graphic
graphic
graphic
graphic
graphic
graphic
graphic
 
  
Labs Table
LabDate
ALT
AST
Basophils
Calcium
Chloride
Creatinine Serum
Eosino-    phils
Glucose
Hemato-    crit
Hemo-    globin
Lympho-    cytes
2/21/08
47
24
 
9.4
103
0.8
 
96
38.4
12.7
5
4/29/08
23
18
0.5
10
110
0.7
1.6
97
36
12.2
17.4
  
Efficacy Variables
graphic
graphic
graphic
  
Efficacy Endpoints Table
Date
Burn
Itch
Pain
2/21/08
1.5
1.5
1.5
4/29/08
1
1.5
1
5/15/08
0
0
3
6/15/08
0.5
33
0
7/15/08
4
13
0
7/30/08
3
7
0
8/3/08
2.5
7.5
3.5
8/15/08
3.5
6
6.5
  
 
Fake Clinical Trial
Patient Profiles
3/26/2012