FileMan FileNo | FileMan Filename | Package |
---|---|---|
120.85 | ADVERSE REACTION REPORTING | Adverse Reaction Tracking |
Package | Total | FileMan Files |
---|---|---|
Adverse Reaction Tracking | 2 | PATIENT ALLERGIES(#120.8)[.03] SIGN/SYMPTOMS(#120.83)[#120.8502(.01)] |
Kernel | 2 | STATE(#5)[48, 58] NEW PERSON(#200)[.5, 1.2, #120.8502(2)] |
Registration | 1 | PATIENT(#2)[.02] |
Field # | Name | Loc | Type | Details |
---|---|---|---|---|
.01 | DATE/TIME OF EVENT | 0;1 | DATE | ************************REQUIRED FIELD************************
|
.02 | PATIENT | 0;2 | POINTER TO PATIENT FILE (#2) | ************************REQUIRED FIELD************************ PATIENT(#2)
|
.03 | RELATED REACTION | 0;15 | POINTER TO PATIENT ALLERGIES FILE (#120.8) | ************************REQUIRED FIELD************************ PATIENT ALLERGIES(#120.8)
|
.5 | OBSERVER | 0;13 | POINTER TO NEW PERSON FILE (#200) | NEW PERSON(#200)
|
1.1 | DATE REPORTED | 0;18 | DATE |
|
1.2 | REPORTING USER | 0;19 | POINTER TO NEW PERSON FILE (#200) | NEW PERSON(#200)
|
2 | REACTIONS | 2;0 | POINTER Multiple #120.8502 | 120.8502
|
3 | SUSPECTED AGENT | 3;0 | Multiple #120.8503 | 120.8503
|
4 | RELEVANT TEST/LAB DATA | 4;0 | Multiple #120.8504 | 120.8504
|
5 | QUESTION #1 | 0;3 | SET |
|
6 | QUESTION #2 | 0;4 | SET |
|
7 | QUESTION #3 | 0;5 | SET |
|
8 | QUESTION #4 | 0;6 | SET |
|
9 | QUESTION #5 | 0;7 | SET |
|
9.1 | NO. DAY HOSPITALIZED | 0;8 | NUMBER |
|
10 | QUESTION #6 | 0;9 | SET |
|
11 | QUESTION #7 | 0;10 | SET |
|
12 | QUESTION #8 | 0;11 | SET |
|
12.1 | QUESTION #9 | 0;16 | SET |
|
12.2 | QUESTION #10 | 0;17 | SET |
|
13 | CONCOMITANT DRUGS | 13;0 | Multiple #120.8513 | 120.8513
|
14 | OTHER RELATED HISTORY | 14;0 | WORD-PROCESSING #120.8514 |
|
14.5 | SEVERITY | 0;14 | SET |
|
22 | DATE MD NOTIFIED | 0;12 | DATE |
|
23 | FDA QUESTION #1 | PTC1;1 | SET |
|
24 | FDA QUESTION #2 | PTC1;2 | SET |
|
25 | FDA QUESTION #3 | PTC1;3 | SET |
|
26 | FDA QUESTION #4 | PTC1;4 | SET |
|
26.1 | FDA QUESTION #5 | PTC1;13 | SET |
|
27 | DATE REPORTED TO FDA | PTC1;5 | DATE |
|
28 | DATE OF PATIENT CONSENT TO MFR | PTC1;6 | DATE |
|
29 | DATE SENT TO MFR | PTC1;7 | DATE |
|
30 | *DATE SENT TO RCPM | PTC1;8 | DATE |
|
31 | DATE SENT TO VAERS | PTC1;9 | DATE |
|
31.1 | P&T ACTION FDA REPORT | PTC1;10 | SET |
|
31.2 | P&T ACTION MFR REPORT | PTC1;11 | SET |
|
31.3 | *P&T ACTION RCPM REPORT | PTC1;12 | SET |
|
31.5 | P&T ADDENDUM | PTC2;0 | DATE Multiple #120.85315 | 120.85315
|
43 | REPORTER NAME | RPT;1 | FREE TEXT |
|
44 | REPORTER ADDRESS1 | RPT;2 | FREE TEXT |
|
45 | REPORTER ADDRESS2 | RPT;3 | FREE TEXT |
|
46 | REPORTER ADDRESS3 | RPT;4 | FREE TEXT |
|
47 | REPORTER CITY | RPT;5 | FREE TEXT |
|
48 | REPORTER STATE | RPT;6 | POINTER TO STATE FILE (#5) | STATE(#5)
|
49 | REPORTER ZIP | RPT;7 | FREE TEXT |
|
50 | REPORTER PHONE | RPT;8 | FREE TEXT |
|
51 | RPT QUESTION #1 | RPT;9 | SET |
|
52 | RPT QUESTION #2 | RPT;10 | SET |
|
52.1 | OCCUPATION | RPT;11 | FREE TEXT |
|
53 | MANUFACTURER NAME | MFR1;1 | FREE TEXT |
|
54 | MFR ADDRESS #1 | MFR1;2 | FREE TEXT |
|
55 | MFR ADDRESS #2 | MFR1;3 | FREE TEXT |
|
56 | MFR ADDRESS #3 | MFR1;4 | FREE TEXT |
|
57 | MFR CITY | MFR1;5 | FREE TEXT |
|
58 | MFR STATE | MFR1;6 | POINTER TO STATE FILE (#5) | STATE(#5)
|
59 | MFR ZIP | MFR1;7 | FREE TEXT |
|
60 | IND/NDA # FOR SUPPORT DRUG | MFR2;1 | FREE TEXT |
|
61 | MFR CONTROL # | MFR2;2 | FREE TEXT |
|
62 | DATE RECEIVED BY MFR | MFR2;3 | DATE |
|
63 | REPORT SOURCE | 63;0 | SET Multiple #120.8563 | 120.8563
|
64 | 15 DAY REPORT | MFR2;4 | SET |
|
65 | REPORT TYPE | MFR2;5 | SET |
|
ICR LINK | Subscribing Package(s) | Fields Referenced | Description |
---|---|---|---|
ICR #5190 |
Name | Field # of Occurrence |
---|---|
^%DT | .01+1, 1.1+1, 27+1, 28+1, 29+1, 30+1, 31+1, 62+1 |
EN^DDIOL | IDWRITE+1, 43OF9.3+1, 53OF9.3+1 |
^DIC | .02+1, .03+1, 43OF9.2+1, 53OF9.2+1 |
YN^DICN | 43OF9.3+1, 53OF9.3+1 |
DQ^DICQ | 43(HELP ), 53(HELP ) |
Y^DIQ | ID.02+1 |
EN4^GMRAFUT0 | .01+1, 22+1 |
KILLOB^GMRAHDR | IXAHDRKL+1 |
SETOB^GMRAHDR | IXAHDRSL+1 |
EN1^GMRAHUT0 | 14.5(HELP ) |
Name | Line Occurrences (* Changed, ! Killed) |
---|---|
^DD(120.85 | 43+1, 43OF9.2+1, 53+1, 53OF9.2+1 |
^DD(2 | ID.02+1 |
^DPT - [#2] | ID.02+1 |
^GMR(120.8 - [#120.8] | IDWRITE+1, .03OT+1 |
^GMR(120.85 - [#120.85] | .01(XREF 1S), .01(XREF 1K), .02(XREF 1S), .02(XREF 1K), .03(XREF 1S), .03(XREF 1K), 1.1(XREF 1S), 1.1(XREF 1K) |
Name | Field # of Occurrence |
---|---|
^(0 | ID.02+1, IDWRITE+1 |
>> | Not killed explicitly |
* | Changed |
! | Killed |
~ | Newed |
Name | Field # of Occurrence |
---|---|
>> % | 43OF9.3+1*, 53OF9.3+1* |
>> %DT | .01+1*, 1.1+1*, 27+1*, 28+1*, 29+1*, 30+1*, 31+1*, 62+1* |
>> %DT(0 | 27+1*!, 28+1*!, 29+1*!, 30+1*!, 31+1*!, 62+1*! |
%I | ID.02+1*! |
>> C | ID.02+1* |
D | 43(HELP ), 53(HELP ) |
>> DA | .01(XREF 1S), .01(XREF 1K), .02(XREF 1S), .02(XREF 1K), .03(XREF 1S), .03(XREF 1K), 1.1(XREF 1S), 1.1(XREF 1K) |
DIC | ID.02+1, IDWRITE+1, .02+1!*, .03+1!*, 43(HELP ), 43OF9.2+1~*, 53(HELP ), 53OF9.2+1~* |
DIC("S" | .02+1*, .02SCR+1*, .03+1*, .03SCR+1* |
DIC(0 | 43(HELP ), 43OF9.2+1*, 53(HELP ), 53OF9.2+1* |
DICR | 43OF9.2+1~, 53OF9.2+1~ |
>> DIE | .02+1, .03+1 |
>> DIU(0 | IXAHDRSL+1, IXAHDRKL+1 |
DIX | 43OF9.2+1~, 53OF9.2+1~ |
DO | 43(HELP ), 43OF9.2+1~, 53(HELP ), 53OF9.2+1~ |
>> DTOUT | 43OF9.2+1, 53OF9.2+1 |
>> DZ | 43(HELP ) |
>> GMRA | .01+1*, 22+1* |
GMRAHLPX | IDWRITE+1*!, 43OF9.3+1*!, 53OF9.3+1*! |
U | ID.02+1, IDWRITE+1, .03OT+1, 43OF9.2+1, 53OF9.2+1 |
X | .01+1*!, .01(XREF 1S), .01(XREF 1K), .02+1*!, .02(XREF 1S), .02(XREF 1K), .03+1*!, .03(XREF 1S), .03(XREF 1K), 1.1+1*! , 1.1(XREF 1S), 1.1(XREF 1K), 9.1+1!, 27+1*!, 28+1*!, 29+1*!, 30+1*!, 31+1*!, 43+1!, 43OF9.2+1* , 43OF9.3+1*, 44+1!, 45+1!, 46+1!, 47+1!, 49+1!, 50+1!, 52.1+1!, 53+1!, 53OF9.2+1* , 53OF9.3+1*, 54+1!, 55+1!, 56+1!, 57+1!, 59+1!, 60+1!, 61+1!, 62+1*! |
>> Y | ID.02+1*, IDWRITE+1, .01+1, .02+1, .03+1, .03OT+1*, 1.1+1, 27+1, 28+1, 29+1 , 30+1, 31+1, 43OF9.2+1*, 43OF9.3+1*, 53OF9.2+1*, 53OF9.3+1*, 62+1 |
>> Y(0 | .03OT+1* |