|
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 *
|
|
|
|
* 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
| ||||||||
|
|
|
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
| ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
| ||
|
|
|
|
|
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
|