Nothing
tests/testthat/_snaps/ael03.md
In chevron: Standard TLGs for Clinical Trials Reporting
ael03 works with adae dataset
Code
cat(export_as_txt(res, lpp = 100, cpp = 110))
Output
ACTARM: A: Drug X
—————————————————————————————————————————————————————————————————————————————————————————————————————————
Date of
Adverse First Study Study AE
Event MedDRA Drug Day of Duration
Center/Patients ID Age/Sex/Race Preferred Term Administration Onset in Days
—————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN dcd A.1.1.1.2 28APR2019 1007 68
CHN-14/1 27/F/ASIAN dcd A.1.1.1.2 07MAY2019 258 657
dcd B.2.2.3.1 07MAY2019 385 20
dcd B.1.1.1.1 07MAY2019 517 280
CHN-17/309 36/F/ASIAN dcd B.2.2.3.1 27APR2019 344 495
dcd D.1.1.1.1 27APR2019 495 485
CHN-2/286 30/F/ASIAN dcd D.1.1.1.1 16MAY2019 157 611
dcd B.2.2.3.1 16MAY2019 488 104
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN dcd D.1.1.1.1 27APR2019 55 796
CHN-4/73 24/F/ASIAN dcd B.2.2.3.1 17MAR2019 163 74
\s\nACTARM: A: Drug X
——————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by Action
Extreme Study Outcome Treatment Taken
Center/Patients ID Age/Sex/Race Intensity Drug (1) for AE (2)
——————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN MODERATE No 3 Yes 2
CHN-14/1 27/F/ASIAN MODERATE No 2 No 2
MILD No 6 Yes 2
SEVERE Yes 1 No 6
CHN-17/309 36/F/ASIAN MILD No 5 Yes 1
SEVERE Yes 1 No 6
CHN-2/286 30/F/ASIAN SEVERE Yes 1 No 6
MILD No 5 No 2
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN SEVERE Yes 1 No 6
CHN-4/73 24/F/ASIAN MILD No 6 Yes 3
\s\nACTARM: A: Drug X
————————————————————————————————————————————————————————————————
Reason
Classified
as Serious
Center/Patients ID Age/Sex/Race (3)
————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN 5
CHN-14/1 27/F/ASIAN 4
6
1
CHN-17/309 36/F/ASIAN 3
1
CHN-2/286 30/F/ASIAN 1
6
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN 1
CHN-4/73 24/F/ASIAN 6
\s\nACTARM: B: Placebo
—————————————————————————————————————————————————————————————————————————————————————————————————————————
Date of
Adverse First Study Study AE
Event MedDRA Drug Day of Duration
Center/Patients ID Age/Sex/Race Preferred Term Administration Onset in Days
—————————————————————————————————————————————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN dcd A.1.1.1.2 23MAY2019 57 326
dcd B.1.1.1.1 23MAY2019 434 409
dcd A.1.1.1.2 23MAY2019 454 506
dcd A.1.1.1.2 23MAY2019 523 391
dcd A.1.1.1.2 23MAY2019 769 73
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN dcd A.1.1.1.2 09APR2019 685 309
dcd B.2.2.3.1 09APR2019 803 129
CHN-11/220 26/F/ASIAN dcd D.1.1.1.1 01MAR2019 876 175
dcd B.1.1.1.1 01MAR2019 910 162
CHN-11/38 25/F/WHITE dcd A.1.1.1.2 17JUN2019 523 536
\s\nACTARM: B: Placebo
——————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by Action
Extreme Study Outcome Treatment Taken
Center/Patients ID Age/Sex/Race Intensity Drug (1) for AE (2)
——————————————————————————————————————————————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN MODERATE No 5 Yes 2
SEVERE Yes 1 No 6
MODERATE No 6 No 1
MODERATE No 3 Yes 3
MODERATE No 5 No 2
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN MODERATE No 6 Yes 2
MILD No 6 No 6
CHN-11/220 26/F/ASIAN SEVERE Yes 1 No 6
SEVERE Yes 1 No 6
CHN-11/38 25/F/WHITE MODERATE No 2 No 2
\s\nACTARM: B: Placebo
————————————————————————————————————————————————————————————————
Reason
Classified
as Serious
Center/Patients ID Age/Sex/Race (3)
————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN 6
1
3
6
5
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN 3
6
CHN-11/220 26/F/ASIAN 1
1
CHN-11/38 25/F/WHITE 5
\s\nACTARM: C: Combination
—————————————————————————————————————————————————————————————————————————————————————————————————————————
Date of
Adverse First Study Study AE
Event MedDRA Drug Day of Duration
Center/Patients ID Age/Sex/Race Preferred Term Administration Onset in Days
—————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN dcd B.2.2.3.1 25MAR2019 441 53
dcd D.1.1.1.1 25MAR2019 445 598
dcd B.1.1.1.1 25MAR2019 644 42
dcd B.2.2.3.1 25MAR2019 669 100
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN dcd D.1.1.1.1 28APR2019 92 254
dcd A.1.1.1.2 28APR2019 449 516
dcd A.1.1.1.2 28APR2019 593 51
dcd D.1.1.1.1 28APR2019 671 32
dcd D.1.1.1.1 28APR2019 937 36
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN dcd B.1.1.1.1 26FEB2019 124 456
\s\nACTARM: C: Combination
——————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by Action
Extreme Study Outcome Treatment Taken
Center/Patients ID Age/Sex/Race Intensity Drug (1) for AE (2)
——————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN MILD No 5 No 2
SEVERE Yes 1 No 6
SEVERE Yes 1 No 6
MILD No 5 Yes 2
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN SEVERE Yes 1 No 6
MODERATE No 5 Yes 3
MODERATE No 5 Yes 3
SEVERE Yes 1 No 6
SEVERE Yes 1 No 6
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN SEVERE Yes 1 No 6
\s\nACTARM: C: Combination
————————————————————————————————————————————————————————————————
Reason
Classified
as Serious
Center/Patients ID Age/Sex/Race (3)
————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN 3
1
1
3
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN 1
6
3
1
1
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN 1
ael03 can handle all missing values
Code
cat(export_as_txt(res[[1]][1:50, ], lpp = 100, cpp = 110))
Output
ACTARM: <Missing>
—————————————————————————————————————————————————————————————————————————————————————————————————————————
Date of
Adverse First Study Study AE
Event MedDRA Drug Day of Duration
Center/Patients ID Age/Sex/Race Preferred Term Administration Onset in Days
—————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN <Missing> 28APR2019 1007 68
BRA-11/9 40/M/ASIAN <Missing> 25MAR2019 441 53
<Missing> 25MAR2019 445 598
<Missing> 25MAR2019 644 42
<Missing> 25MAR2019 669 100
CAN-1/341 43/F/ASIAN <Missing> 23MAY2019 57 326
<Missing> 23MAY2019 434 409
<Missing> 23MAY2019 454 506
<Missing> 23MAY2019 523 391
<Missing> 23MAY2019 769 73
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN <Missing> 09APR2019 685 309
<Missing> 09APR2019 803 129
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN <Missing> 28APR2019 92 254
<Missing> 28APR2019 449 516
<Missing> 28APR2019 593 51
<Missing> 28APR2019 671 32
<Missing> 28APR2019 937 36
CHN-11/220 26/F/ASIAN <Missing> 01MAR2019 876 175
<Missing> 01MAR2019 910 162
CHN-11/38 25/F/WHITE <Missing> 17JUN2019 523 536
CHN-13/102 37/M/ASIAN <Missing> 23MAR2019 34 555
<Missing> 23MAR2019 65 400
<Missing> 23MAR2019 184 446
<Missing> 23MAR2019 439 515
<Missing> 23MAR2019 870 58
CHN-14/1 27/F/ASIAN <Missing> 07MAY2019 258 657
<Missing> 07MAY2019 385 20
<Missing> 07MAY2019 517 280
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN <Missing> 26FEB2019 124 456
<Missing> 26FEB2019 337 140
<Missing> 26FEB2019 1051 21
CHN-17/309 36/F/ASIAN <Missing> 27APR2019 344 495
<Missing> 27APR2019 495 485
CHN-17/48 32/F/ASIAN <Missing> 03MAY2019 20 255
CHN-17/84 40/F/ASIAN <Missing> 24MAR2019 19 1020
<Missing> 24MAR2019 595 414
<Missing> 24MAR2019 830 132
<Missing> 24MAR2019 851 209
CHN-2/286 30/F/ASIAN <Missing> 16MAY2019 157 611
<Missing> 16MAY2019 488 104
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN <Missing> 27APR2019 55 796
CHN-4/115 38/M/ASIAN <Missing> 28MAR2019 298 699
<Missing> 28MAR2019 610 130
<Missing> 28MAR2019 769 104
<Missing> 28MAR2019 806 200
<Missing> 28MAR2019 990 72
CHN-4/370 45/M/ASIAN <Missing> 29MAR2019 594 19
<Missing> 29MAR2019 740 60
<Missing> 29MAR2019 856 187
<Missing> 29MAR2019 985 25
\s\nACTARM: <Missing>
——————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by Action
Extreme Study Outcome Treatment Taken
Center/Patients ID Age/Sex/Race Intensity Drug (1) for AE (2)
——————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN <Missing> No 3 Yes 2
BRA-11/9 40/M/ASIAN <Missing> No 5 No 2
<Missing> Yes 1 No 6
<Missing> Yes 1 No 6
<Missing> No 5 Yes 2
CAN-1/341 43/F/ASIAN <Missing> No 5 Yes 2
<Missing> Yes 1 No 6
<Missing> No 6 No 1
<Missing> No 3 Yes 3
<Missing> No 5 No 2
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN <Missing> No 6 Yes 2
<Missing> No 6 No 6
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN <Missing> Yes 1 No 6
<Missing> No 5 Yes 3
<Missing> No 5 Yes 3
<Missing> Yes 1 No 6
<Missing> Yes 1 No 6
CHN-11/220 26/F/ASIAN <Missing> Yes 1 No 6
<Missing> Yes 1 No 6
CHN-11/38 25/F/WHITE <Missing> No 2 No 2
CHN-13/102 37/M/ASIAN <Missing> Yes 1 No 6
<Missing> Yes 1 Yes 6
<Missing> No 3 No 6
<Missing> Yes 1 Yes 6
<Missing> Yes 1 Yes 6
CHN-14/1 27/F/ASIAN <Missing> No 2 No 2
<Missing> No 6 Yes 2
<Missing> Yes 1 No 6
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN <Missing> Yes 1 No 6
<Missing> Yes 1 No 6
<Missing> No 3 Yes 1
CHN-17/309 36/F/ASIAN <Missing> No 5 Yes 1
<Missing> Yes 1 No 6
CHN-17/48 32/F/ASIAN <Missing> Yes 1 Yes 6
CHN-17/84 40/F/ASIAN <Missing> Yes 1 No 6
<Missing> No 5 No 2
<Missing> Yes 1 No 6
<Missing> No 3 No 2
CHN-2/286 30/F/ASIAN <Missing> Yes 1 No 6
<Missing> No 5 No 2
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN <Missing> Yes 1 No 6
CHN-4/115 38/M/ASIAN <Missing> No 3 Yes 2
<Missing> Yes 1 No 6
<Missing> No 3 No 2
<Missing> Yes 1 No 6
<Missing> No 2 No 6
CHN-4/370 45/M/ASIAN <Missing> No 3 No 2
<Missing> No 3 No 6
<Missing> No 4 Yes 3
<Missing> No 3 No 2
\s\nACTARM: <Missing>
————————————————————————————————————————————————————————————————
Reason
Classified
as Serious
Center/Patients ID Age/Sex/Race (3)
————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN 5
BRA-11/9 40/M/ASIAN 3
1
1
3
CAN-1/341 43/F/ASIAN 6
1
3
6
5
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN 3
6
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN 1
6
3
1
1
CHN-11/220 26/F/ASIAN 1
1
CHN-11/38 25/F/WHITE 5
CHN-13/102 37/M/ASIAN 1
1
6
1
1
CHN-14/1 27/F/ASIAN 4
6
1
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN 1
1
3
CHN-17/309 36/F/ASIAN 3
1
CHN-17/48 32/F/ASIAN 1
CHN-17/84 40/F/ASIAN 1
5
1
6
CHN-2/286 30/F/ASIAN 1
6
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN 1
CHN-4/115 38/M/ASIAN 6
1
3
1
5
CHN-4/370 45/M/ASIAN 3
4
5
6
ael03 functions work as expected
Code
cat(export_as_txt(res, lpp = 100, cpp = 110))
Output
ACTARM: A: Drug X
—————————————————————————————————————————————————————————————————————————————————————————————————————————
Date of
Adverse First Study Study AE
Event MedDRA Drug Day of Duration
Center/Patients ID Age/Sex/Race Preferred Term Administration Onset in Days
—————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN dcd A.1.1.1.2 28APR2019 1007 68
CHN-14/1 27/F/ASIAN dcd A.1.1.1.2 07MAY2019 258 657
dcd B.2.2.3.1 07MAY2019 385 20
dcd B.1.1.1.1 07MAY2019 517 280
CHN-17/309 36/F/ASIAN dcd B.2.2.3.1 27APR2019 344 495
dcd D.1.1.1.1 27APR2019 495 485
CHN-2/286 30/F/ASIAN dcd D.1.1.1.1 16MAY2019 157 611
dcd B.2.2.3.1 16MAY2019 488 104
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN dcd D.1.1.1.1 27APR2019 55 796
CHN-4/73 24/F/ASIAN dcd B.2.2.3.1 17MAR2019 163 74
\s\nACTARM: A: Drug X
——————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by Action
Extreme Study Outcome Treatment Taken
Center/Patients ID Age/Sex/Race Intensity Drug (1) for AE (2)
——————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN MODERATE No 3 Yes 2
CHN-14/1 27/F/ASIAN MODERATE No 2 No 2
MILD No 6 Yes 2
SEVERE Yes 1 No 6
CHN-17/309 36/F/ASIAN MILD No 5 Yes 1
SEVERE Yes 1 No 6
CHN-2/286 30/F/ASIAN SEVERE Yes 1 No 6
MILD No 5 No 2
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN SEVERE Yes 1 No 6
CHN-4/73 24/F/ASIAN MILD No 6 Yes 3
\s\nACTARM: A: Drug X
————————————————————————————————————————————————————————————————
Reason
Classified
as Serious
Center/Patients ID Age/Sex/Race (3)
————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN 5
CHN-14/1 27/F/ASIAN 4
6
1
CHN-17/309 36/F/ASIAN 3
1
CHN-2/286 30/F/ASIAN 1
6
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN 1
CHN-4/73 24/F/ASIAN 6
\s\nACTARM: B: Placebo
—————————————————————————————————————————————————————————————————————————————————————————————————————————
Date of
Adverse First Study Study AE
Event MedDRA Drug Day of Duration
Center/Patients ID Age/Sex/Race Preferred Term Administration Onset in Days
—————————————————————————————————————————————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN dcd A.1.1.1.2 23MAY2019 57 326
dcd B.1.1.1.1 23MAY2019 434 409
dcd A.1.1.1.2 23MAY2019 454 506
dcd A.1.1.1.2 23MAY2019 523 391
dcd A.1.1.1.2 23MAY2019 769 73
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN dcd A.1.1.1.2 09APR2019 685 309
dcd B.2.2.3.1 09APR2019 803 129
CHN-11/220 26/F/ASIAN dcd D.1.1.1.1 01MAR2019 876 175
dcd B.1.1.1.1 01MAR2019 910 162
CHN-11/38 25/F/WHITE dcd A.1.1.1.2 17JUN2019 523 536
\s\nACTARM: B: Placebo
——————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by Action
Extreme Study Outcome Treatment Taken
Center/Patients ID Age/Sex/Race Intensity Drug (1) for AE (2)
——————————————————————————————————————————————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN MODERATE No 5 Yes 2
SEVERE Yes 1 No 6
MODERATE No 6 No 1
MODERATE No 3 Yes 3
MODERATE No 5 No 2
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN MODERATE No 6 Yes 2
MILD No 6 No 6
CHN-11/220 26/F/ASIAN SEVERE Yes 1 No 6
SEVERE Yes 1 No 6
CHN-11/38 25/F/WHITE MODERATE No 2 No 2
\s\nACTARM: B: Placebo
————————————————————————————————————————————————————————————————
Reason
Classified
as Serious
Center/Patients ID Age/Sex/Race (3)
————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN 6
1
3
6
5
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN 3
6
CHN-11/220 26/F/ASIAN 1
1
CHN-11/38 25/F/WHITE 5
\s\nACTARM: C: Combination
—————————————————————————————————————————————————————————————————————————————————————————————————————————
Date of
Adverse First Study Study AE
Event MedDRA Drug Day of Duration
Center/Patients ID Age/Sex/Race Preferred Term Administration Onset in Days
—————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN dcd B.2.2.3.1 25MAR2019 441 53
dcd D.1.1.1.1 25MAR2019 445 598
dcd B.1.1.1.1 25MAR2019 644 42
dcd B.2.2.3.1 25MAR2019 669 100
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN dcd D.1.1.1.1 28APR2019 92 254
dcd A.1.1.1.2 28APR2019 449 516
dcd A.1.1.1.2 28APR2019 593 51
dcd D.1.1.1.1 28APR2019 671 32
dcd D.1.1.1.1 28APR2019 937 36
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN dcd B.1.1.1.1 26FEB2019 124 456
\s\nACTARM: C: Combination
——————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by Action
Extreme Study Outcome Treatment Taken
Center/Patients ID Age/Sex/Race Intensity Drug (1) for AE (2)
——————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN MILD No 5 No 2
SEVERE Yes 1 No 6
SEVERE Yes 1 No 6
MILD No 5 Yes 2
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN SEVERE Yes 1 No 6
MODERATE No 5 Yes 3
MODERATE No 5 Yes 3
SEVERE Yes 1 No 6
SEVERE Yes 1 No 6
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN SEVERE Yes 1 No 6
\s\nACTARM: C: Combination
————————————————————————————————————————————————————————————————
Reason
Classified
as Serious
Center/Patients ID Age/Sex/Race (3)
————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN 3
1
1
3
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN 1
6
3
1
1
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN 1
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ael03 works with adae dataset
Code
cat(export_as_txt(res, lpp = 100, cpp = 110))
Output
ACTARM: A: Drug X
—————————————————————————————————————————————————————————————————————————————————————————————————————————
Date of
Adverse First Study Study AE
Event MedDRA Drug Day of Duration
Center/Patients ID Age/Sex/Race Preferred Term Administration Onset in Days
—————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN dcd A.1.1.1.2 28APR2019 1007 68
CHN-14/1 27/F/ASIAN dcd A.1.1.1.2 07MAY2019 258 657
dcd B.2.2.3.1 07MAY2019 385 20
dcd B.1.1.1.1 07MAY2019 517 280
CHN-17/309 36/F/ASIAN dcd B.2.2.3.1 27APR2019 344 495
dcd D.1.1.1.1 27APR2019 495 485
CHN-2/286 30/F/ASIAN dcd D.1.1.1.1 16MAY2019 157 611
dcd B.2.2.3.1 16MAY2019 488 104
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN dcd D.1.1.1.1 27APR2019 55 796
CHN-4/73 24/F/ASIAN dcd B.2.2.3.1 17MAR2019 163 74
\s\nACTARM: A: Drug X
——————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by Action
Extreme Study Outcome Treatment Taken
Center/Patients ID Age/Sex/Race Intensity Drug (1) for AE (2)
——————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN MODERATE No 3 Yes 2
CHN-14/1 27/F/ASIAN MODERATE No 2 No 2
MILD No 6 Yes 2
SEVERE Yes 1 No 6
CHN-17/309 36/F/ASIAN MILD No 5 Yes 1
SEVERE Yes 1 No 6
CHN-2/286 30/F/ASIAN SEVERE Yes 1 No 6
MILD No 5 No 2
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN SEVERE Yes 1 No 6
CHN-4/73 24/F/ASIAN MILD No 6 Yes 3
\s\nACTARM: A: Drug X
————————————————————————————————————————————————————————————————
Reason
Classified
as Serious
Center/Patients ID Age/Sex/Race (3)
————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN 5
CHN-14/1 27/F/ASIAN 4
6
1
CHN-17/309 36/F/ASIAN 3
1
CHN-2/286 30/F/ASIAN 1
6
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN 1
CHN-4/73 24/F/ASIAN 6
\s\nACTARM: B: Placebo
—————————————————————————————————————————————————————————————————————————————————————————————————————————
Date of
Adverse First Study Study AE
Event MedDRA Drug Day of Duration
Center/Patients ID Age/Sex/Race Preferred Term Administration Onset in Days
—————————————————————————————————————————————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN dcd A.1.1.1.2 23MAY2019 57 326
dcd B.1.1.1.1 23MAY2019 434 409
dcd A.1.1.1.2 23MAY2019 454 506
dcd A.1.1.1.2 23MAY2019 523 391
dcd A.1.1.1.2 23MAY2019 769 73
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN dcd A.1.1.1.2 09APR2019 685 309
dcd B.2.2.3.1 09APR2019 803 129
CHN-11/220 26/F/ASIAN dcd D.1.1.1.1 01MAR2019 876 175
dcd B.1.1.1.1 01MAR2019 910 162
CHN-11/38 25/F/WHITE dcd A.1.1.1.2 17JUN2019 523 536
\s\nACTARM: B: Placebo
——————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by Action
Extreme Study Outcome Treatment Taken
Center/Patients ID Age/Sex/Race Intensity Drug (1) for AE (2)
——————————————————————————————————————————————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN MODERATE No 5 Yes 2
SEVERE Yes 1 No 6
MODERATE No 6 No 1
MODERATE No 3 Yes 3
MODERATE No 5 No 2
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN MODERATE No 6 Yes 2
MILD No 6 No 6
CHN-11/220 26/F/ASIAN SEVERE Yes 1 No 6
SEVERE Yes 1 No 6
CHN-11/38 25/F/WHITE MODERATE No 2 No 2
\s\nACTARM: B: Placebo
————————————————————————————————————————————————————————————————
Reason
Classified
as Serious
Center/Patients ID Age/Sex/Race (3)
————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN 6
1
3
6
5
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN 3
6
CHN-11/220 26/F/ASIAN 1
1
CHN-11/38 25/F/WHITE 5
\s\nACTARM: C: Combination
—————————————————————————————————————————————————————————————————————————————————————————————————————————
Date of
Adverse First Study Study AE
Event MedDRA Drug Day of Duration
Center/Patients ID Age/Sex/Race Preferred Term Administration Onset in Days
—————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN dcd B.2.2.3.1 25MAR2019 441 53
dcd D.1.1.1.1 25MAR2019 445 598
dcd B.1.1.1.1 25MAR2019 644 42
dcd B.2.2.3.1 25MAR2019 669 100
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN dcd D.1.1.1.1 28APR2019 92 254
dcd A.1.1.1.2 28APR2019 449 516
dcd A.1.1.1.2 28APR2019 593 51
dcd D.1.1.1.1 28APR2019 671 32
dcd D.1.1.1.1 28APR2019 937 36
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN dcd B.1.1.1.1 26FEB2019 124 456
\s\nACTARM: C: Combination
——————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by Action
Extreme Study Outcome Treatment Taken
Center/Patients ID Age/Sex/Race Intensity Drug (1) for AE (2)
——————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN MILD No 5 No 2
SEVERE Yes 1 No 6
SEVERE Yes 1 No 6
MILD No 5 Yes 2
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN SEVERE Yes 1 No 6
MODERATE No 5 Yes 3
MODERATE No 5 Yes 3
SEVERE Yes 1 No 6
SEVERE Yes 1 No 6
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN SEVERE Yes 1 No 6
\s\nACTARM: C: Combination
————————————————————————————————————————————————————————————————
Reason
Classified
as Serious
Center/Patients ID Age/Sex/Race (3)
————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN 3
1
1
3
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN 1
6
3
1
1
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN 1
ael03 can handle all missing values
Code
cat(export_as_txt(res[[1]][1:50, ], lpp = 100, cpp = 110))
Output
ACTARM: <Missing>
—————————————————————————————————————————————————————————————————————————————————————————————————————————
Date of
Adverse First Study Study AE
Event MedDRA Drug Day of Duration
Center/Patients ID Age/Sex/Race Preferred Term Administration Onset in Days
—————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN <Missing> 28APR2019 1007 68
BRA-11/9 40/M/ASIAN <Missing> 25MAR2019 441 53
<Missing> 25MAR2019 445 598
<Missing> 25MAR2019 644 42
<Missing> 25MAR2019 669 100
CAN-1/341 43/F/ASIAN <Missing> 23MAY2019 57 326
<Missing> 23MAY2019 434 409
<Missing> 23MAY2019 454 506
<Missing> 23MAY2019 523 391
<Missing> 23MAY2019 769 73
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN <Missing> 09APR2019 685 309
<Missing> 09APR2019 803 129
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN <Missing> 28APR2019 92 254
<Missing> 28APR2019 449 516
<Missing> 28APR2019 593 51
<Missing> 28APR2019 671 32
<Missing> 28APR2019 937 36
CHN-11/220 26/F/ASIAN <Missing> 01MAR2019 876 175
<Missing> 01MAR2019 910 162
CHN-11/38 25/F/WHITE <Missing> 17JUN2019 523 536
CHN-13/102 37/M/ASIAN <Missing> 23MAR2019 34 555
<Missing> 23MAR2019 65 400
<Missing> 23MAR2019 184 446
<Missing> 23MAR2019 439 515
<Missing> 23MAR2019 870 58
CHN-14/1 27/F/ASIAN <Missing> 07MAY2019 258 657
<Missing> 07MAY2019 385 20
<Missing> 07MAY2019 517 280
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN <Missing> 26FEB2019 124 456
<Missing> 26FEB2019 337 140
<Missing> 26FEB2019 1051 21
CHN-17/309 36/F/ASIAN <Missing> 27APR2019 344 495
<Missing> 27APR2019 495 485
CHN-17/48 32/F/ASIAN <Missing> 03MAY2019 20 255
CHN-17/84 40/F/ASIAN <Missing> 24MAR2019 19 1020
<Missing> 24MAR2019 595 414
<Missing> 24MAR2019 830 132
<Missing> 24MAR2019 851 209
CHN-2/286 30/F/ASIAN <Missing> 16MAY2019 157 611
<Missing> 16MAY2019 488 104
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN <Missing> 27APR2019 55 796
CHN-4/115 38/M/ASIAN <Missing> 28MAR2019 298 699
<Missing> 28MAR2019 610 130
<Missing> 28MAR2019 769 104
<Missing> 28MAR2019 806 200
<Missing> 28MAR2019 990 72
CHN-4/370 45/M/ASIAN <Missing> 29MAR2019 594 19
<Missing> 29MAR2019 740 60
<Missing> 29MAR2019 856 187
<Missing> 29MAR2019 985 25
\s\nACTARM: <Missing>
——————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by Action
Extreme Study Outcome Treatment Taken
Center/Patients ID Age/Sex/Race Intensity Drug (1) for AE (2)
——————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN <Missing> No 3 Yes 2
BRA-11/9 40/M/ASIAN <Missing> No 5 No 2
<Missing> Yes 1 No 6
<Missing> Yes 1 No 6
<Missing> No 5 Yes 2
CAN-1/341 43/F/ASIAN <Missing> No 5 Yes 2
<Missing> Yes 1 No 6
<Missing> No 6 No 1
<Missing> No 3 Yes 3
<Missing> No 5 No 2
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN <Missing> No 6 Yes 2
<Missing> No 6 No 6
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN <Missing> Yes 1 No 6
<Missing> No 5 Yes 3
<Missing> No 5 Yes 3
<Missing> Yes 1 No 6
<Missing> Yes 1 No 6
CHN-11/220 26/F/ASIAN <Missing> Yes 1 No 6
<Missing> Yes 1 No 6
CHN-11/38 25/F/WHITE <Missing> No 2 No 2
CHN-13/102 37/M/ASIAN <Missing> Yes 1 No 6
<Missing> Yes 1 Yes 6
<Missing> No 3 No 6
<Missing> Yes 1 Yes 6
<Missing> Yes 1 Yes 6
CHN-14/1 27/F/ASIAN <Missing> No 2 No 2
<Missing> No 6 Yes 2
<Missing> Yes 1 No 6
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN <Missing> Yes 1 No 6
<Missing> Yes 1 No 6
<Missing> No 3 Yes 1
CHN-17/309 36/F/ASIAN <Missing> No 5 Yes 1
<Missing> Yes 1 No 6
CHN-17/48 32/F/ASIAN <Missing> Yes 1 Yes 6
CHN-17/84 40/F/ASIAN <Missing> Yes 1 No 6
<Missing> No 5 No 2
<Missing> Yes 1 No 6
<Missing> No 3 No 2
CHN-2/286 30/F/ASIAN <Missing> Yes 1 No 6
<Missing> No 5 No 2
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN <Missing> Yes 1 No 6
CHN-4/115 38/M/ASIAN <Missing> No 3 Yes 2
<Missing> Yes 1 No 6
<Missing> No 3 No 2
<Missing> Yes 1 No 6
<Missing> No 2 No 6
CHN-4/370 45/M/ASIAN <Missing> No 3 No 2
<Missing> No 3 No 6
<Missing> No 4 Yes 3
<Missing> No 3 No 2
\s\nACTARM: <Missing>
————————————————————————————————————————————————————————————————
Reason
Classified
as Serious
Center/Patients ID Age/Sex/Race (3)
————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN 5
BRA-11/9 40/M/ASIAN 3
1
1
3
CAN-1/341 43/F/ASIAN 6
1
3
6
5
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN 3
6
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN 1
6
3
1
1
CHN-11/220 26/F/ASIAN 1
1
CHN-11/38 25/F/WHITE 5
CHN-13/102 37/M/ASIAN 1
1
6
1
1
CHN-14/1 27/F/ASIAN 4
6
1
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN 1
1
3
CHN-17/309 36/F/ASIAN 3
1
CHN-17/48 32/F/ASIAN 1
CHN-17/84 40/F/ASIAN 1
5
1
6
CHN-2/286 30/F/ASIAN 1
6
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN 1
CHN-4/115 38/M/ASIAN 6
1
3
1
5
CHN-4/370 45/M/ASIAN 3
4
5
6
ael03 functions work as expected
Code
cat(export_as_txt(res, lpp = 100, cpp = 110))
Output
ACTARM: A: Drug X
—————————————————————————————————————————————————————————————————————————————————————————————————————————
Date of
Adverse First Study Study AE
Event MedDRA Drug Day of Duration
Center/Patients ID Age/Sex/Race Preferred Term Administration Onset in Days
—————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN dcd A.1.1.1.2 28APR2019 1007 68
CHN-14/1 27/F/ASIAN dcd A.1.1.1.2 07MAY2019 258 657
dcd B.2.2.3.1 07MAY2019 385 20
dcd B.1.1.1.1 07MAY2019 517 280
CHN-17/309 36/F/ASIAN dcd B.2.2.3.1 27APR2019 344 495
dcd D.1.1.1.1 27APR2019 495 485
CHN-2/286 30/F/ASIAN dcd D.1.1.1.1 16MAY2019 157 611
dcd B.2.2.3.1 16MAY2019 488 104
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN dcd D.1.1.1.1 27APR2019 55 796
CHN-4/73 24/F/ASIAN dcd B.2.2.3.1 17MAR2019 163 74
\s\nACTARM: A: Drug X
——————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by Action
Extreme Study Outcome Treatment Taken
Center/Patients ID Age/Sex/Race Intensity Drug (1) for AE (2)
——————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN MODERATE No 3 Yes 2
CHN-14/1 27/F/ASIAN MODERATE No 2 No 2
MILD No 6 Yes 2
SEVERE Yes 1 No 6
CHN-17/309 36/F/ASIAN MILD No 5 Yes 1
SEVERE Yes 1 No 6
CHN-2/286 30/F/ASIAN SEVERE Yes 1 No 6
MILD No 5 No 2
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN SEVERE Yes 1 No 6
CHN-4/73 24/F/ASIAN MILD No 6 Yes 3
\s\nACTARM: A: Drug X
————————————————————————————————————————————————————————————————
Reason
Classified
as Serious
Center/Patients ID Age/Sex/Race (3)
————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN 5
CHN-14/1 27/F/ASIAN 4
6
1
CHN-17/309 36/F/ASIAN 3
1
CHN-2/286 30/F/ASIAN 1
6
CHN-2/395 28/M/BLACK OR AFRICAN AMERICAN 1
CHN-4/73 24/F/ASIAN 6
\s\nACTARM: B: Placebo
—————————————————————————————————————————————————————————————————————————————————————————————————————————
Date of
Adverse First Study Study AE
Event MedDRA Drug Day of Duration
Center/Patients ID Age/Sex/Race Preferred Term Administration Onset in Days
—————————————————————————————————————————————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN dcd A.1.1.1.2 23MAY2019 57 326
dcd B.1.1.1.1 23MAY2019 434 409
dcd A.1.1.1.2 23MAY2019 454 506
dcd A.1.1.1.2 23MAY2019 523 391
dcd A.1.1.1.2 23MAY2019 769 73
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN dcd A.1.1.1.2 09APR2019 685 309
dcd B.2.2.3.1 09APR2019 803 129
CHN-11/220 26/F/ASIAN dcd D.1.1.1.1 01MAR2019 876 175
dcd B.1.1.1.1 01MAR2019 910 162
CHN-11/38 25/F/WHITE dcd A.1.1.1.2 17JUN2019 523 536
\s\nACTARM: B: Placebo
——————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by Action
Extreme Study Outcome Treatment Taken
Center/Patients ID Age/Sex/Race Intensity Drug (1) for AE (2)
——————————————————————————————————————————————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN MODERATE No 5 Yes 2
SEVERE Yes 1 No 6
MODERATE No 6 No 1
MODERATE No 3 Yes 3
MODERATE No 5 No 2
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN MODERATE No 6 Yes 2
MILD No 6 No 6
CHN-11/220 26/F/ASIAN SEVERE Yes 1 No 6
SEVERE Yes 1 No 6
CHN-11/38 25/F/WHITE MODERATE No 2 No 2
\s\nACTARM: B: Placebo
————————————————————————————————————————————————————————————————
Reason
Classified
as Serious
Center/Patients ID Age/Sex/Race (3)
————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN 6
1
3
6
5
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN 3
6
CHN-11/220 26/F/ASIAN 1
1
CHN-11/38 25/F/WHITE 5
\s\nACTARM: C: Combination
—————————————————————————————————————————————————————————————————————————————————————————————————————————
Date of
Adverse First Study Study AE
Event MedDRA Drug Day of Duration
Center/Patients ID Age/Sex/Race Preferred Term Administration Onset in Days
—————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN dcd B.2.2.3.1 25MAR2019 441 53
dcd D.1.1.1.1 25MAR2019 445 598
dcd B.1.1.1.1 25MAR2019 644 42
dcd B.2.2.3.1 25MAR2019 669 100
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN dcd D.1.1.1.1 28APR2019 92 254
dcd A.1.1.1.2 28APR2019 449 516
dcd A.1.1.1.2 28APR2019 593 51
dcd D.1.1.1.1 28APR2019 671 32
dcd D.1.1.1.1 28APR2019 937 36
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN dcd B.1.1.1.1 26FEB2019 124 456
\s\nACTARM: C: Combination
——————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by Action
Extreme Study Outcome Treatment Taken
Center/Patients ID Age/Sex/Race Intensity Drug (1) for AE (2)
——————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN MILD No 5 No 2
SEVERE Yes 1 No 6
SEVERE Yes 1 No 6
MILD No 5 Yes 2
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN SEVERE Yes 1 No 6
MODERATE No 5 Yes 3
MODERATE No 5 Yes 3
SEVERE Yes 1 No 6
SEVERE Yes 1 No 6
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN SEVERE Yes 1 No 6
\s\nACTARM: C: Combination
————————————————————————————————————————————————————————————————
Reason
Classified
as Serious
Center/Patients ID Age/Sex/Race (3)
————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN 3
1
1
3
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN 1
6
3
1
1
CHN-15/262 35/M/BLACK OR AFRICAN AMERICAN 1
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