Nothing
tests/testthat/_snaps/ael02.md
In chevron: Standard TLGs for Clinical Trials Reporting
ael02 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 D.1.1.4.2 28APR2019 108 67
dcd C.1.1.1.3 28APR2019 437 39
dcd A.1.1.1.2 28APR2019 1007 68
CHN-14/1 27/F/ASIAN dcd D.1.1.4.2 07MAY2019 193 525
dcd A.1.1.1.1 07MAY2019 194 414
dcd A.1.1.1.2 07MAY2019 258 657
dcd C.1.1.1.3 07MAY2019 367 645
dcd C.2.1.2.1 07MAY2019 371 214
dcd B.2.2.3.1 07MAY2019 385 20
dcd B.1.1.1.1 07MAY2019 517 280
\s\nACTARM: A: Drug X
———————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by
Extreme Study Outcome Treatment
Center/Patients ID Age/Sex/Race Serious Intensity Drug (1) for AE
———————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN No MODERATE No 5 No
No SEVERE Yes 3 No
Yes MODERATE No 3 Yes
CHN-14/1 27/F/ASIAN No MODERATE No 3 Yes
No MILD No 5 Yes
Yes MODERATE No 2 No
No SEVERE Yes 3 Yes
No MODERATE Yes 6 Yes
Yes MILD No 6 Yes
Yes SEVERE Yes 1 No
\s\nACTARM: A: Drug X
————————————————————————————————————————————————————————————
Action
Taken
Center/Patients ID Age/Sex/Race (2)
————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN 5
7
2
CHN-14/1 27/F/ASIAN 3
7
2
2
6
2
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.2.1.2.1 23MAY2019 253 72
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.1.1.1.1 23MAY2019 628 265
dcd C.2.1.2.1 23MAY2019 750 128
dcd A.1.1.1.2 23MAY2019 769 73
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN dcd C.1.1.1.3 09APR2019 253 202
dcd B.2.1.2.1 09APR2019 311 297
\s\nACTARM: B: Placebo
———————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by
Extreme Study Outcome Treatment
Center/Patients ID Age/Sex/Race Serious Intensity Drug (1) for AE
———————————————————————————————————————————————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN Yes MODERATE No 5 Yes
No MODERATE No 5 Yes
Yes SEVERE Yes 1 No
Yes MODERATE No 6 No
Yes MODERATE No 3 Yes
No MILD No 2 Yes
No MODERATE Yes 2 No
Yes MODERATE No 5 No
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN No SEVERE Yes 3 No
No MODERATE No 2 No
\s\nACTARM: B: Placebo
————————————————————————————————————————————————————————————
Action
Taken
Center/Patients ID Age/Sex/Race (2)
————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN 2
2
6
1
3
2
2
2
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN 7
2
\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 D.1.1.4.2 25MAR2019 342 700
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
dcd C.2.1.2.1 25MAR2019 744 185
dcd C.2.1.2.1 25MAR2019 808 166
dcd B.2.1.2.1 25MAR2019 970 15
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN dcd B.2.1.2.1 28APR2019 31 678
dcd D.1.1.1.1 28APR2019 92 254
\s\nACTARM: C: Combination
———————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by
Extreme Study Outcome Treatment
Center/Patients ID Age/Sex/Race Serious Intensity Drug (1) for AE
———————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN No MODERATE No 2 No
Yes MILD No 5 No
Yes SEVERE Yes 1 No
Yes SEVERE Yes 1 No
Yes MILD No 5 Yes
No MODERATE Yes 4 No
No MODERATE Yes 3 No
No MODERATE No 3 No
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN No MODERATE No 6 No
Yes SEVERE Yes 1 No
\s\nACTARM: C: Combination
————————————————————————————————————————————————————————————
Action
Taken
Center/Patients ID Age/Sex/Race (2)
————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN 3
2
6
6
2
3
6
2
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN 1
6
ael02 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 108 67
<Missing> 28APR2019 437 39
<Missing> 28APR2019 1007 68
BRA-11/9 40/M/ASIAN <Missing> 25MAR2019 342 700
<Missing> 25MAR2019 441 53
<Missing> 25MAR2019 445 598
<Missing> 25MAR2019 644 42
<Missing> 25MAR2019 669 100
<Missing> 25MAR2019 744 185
<Missing> 25MAR2019 808 166
<Missing> 25MAR2019 970 15
CAN-1/341 43/F/ASIAN <Missing> 23MAY2019 57 326
<Missing> 23MAY2019 253 72
<Missing> 23MAY2019 434 409
<Missing> 23MAY2019 454 506
<Missing> 23MAY2019 523 391
<Missing> 23MAY2019 628 265
<Missing> 23MAY2019 750 128
<Missing> 23MAY2019 769 73
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN <Missing> 09APR2019 253 202
<Missing> 09APR2019 311 297
<Missing> 09APR2019 400 424
<Missing> 09APR2019 449 300
<Missing> 09APR2019 685 309
<Missing> 09APR2019 803 129
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN <Missing> 28APR2019 31 678
<Missing> 28APR2019 92 254
<Missing> 28APR2019 239 213
<Missing> 28APR2019 365 353
<Missing> 28APR2019 449 516
<Missing> 28APR2019 593 51
<Missing> 28APR2019 671 32
<Missing> 28APR2019 937 36
<Missing> 28APR2019 996 9
CHN-11/220 26/F/ASIAN <Missing> 01MAR2019 406 422
<Missing> 01MAR2019 876 175
<Missing> 01MAR2019 910 162
<Missing> 01MAR2019 979 118
CHN-11/263 34/F/ASIAN <Missing> 03APR2019 140 43
<Missing> 03APR2019 263 147
<Missing> 03APR2019 524 519
<Missing> 03APR2019 714 163
<Missing> 03APR2019 768 277
<Missing> 03APR2019 876 194
<Missing> 03APR2019 955 106
CHN-11/38 25/F/WHITE <Missing> 17JUN2019 523 536
CHN-13/102 37/M/ASIAN <Missing> 23MAR2019 34 555
<Missing> 23MAR2019 55 73
<Missing> 23MAR2019 57 57
<Missing> 23MAR2019 65 400
\s\nACTARM: <Missing>
———————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by
Extreme Study Outcome Treatment
Center/Patients ID Age/Sex/Race Serious Intensity Drug (1) for AE
———————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN No <Missing> No 5 No
No <Missing> Yes 3 No
Yes <Missing> No 3 Yes
BRA-11/9 40/M/ASIAN No <Missing> No 2 No
Yes <Missing> No 5 No
Yes <Missing> Yes 1 No
Yes <Missing> Yes 1 No
Yes <Missing> No 5 Yes
No <Missing> Yes 4 No
No <Missing> Yes 3 No
No <Missing> No 3 No
CAN-1/341 43/F/ASIAN Yes <Missing> No 5 Yes
No <Missing> No 5 Yes
Yes <Missing> Yes 1 No
Yes <Missing> No 6 No
Yes <Missing> No 3 Yes
No <Missing> No 2 Yes
No <Missing> Yes 2 No
Yes <Missing> No 5 No
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN No <Missing> Yes 3 No
No <Missing> No 2 No
No <Missing> Yes 3 No
No <Missing> Yes 5 No
Yes <Missing> No 6 Yes
Yes <Missing> No 6 No
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN No <Missing> No 6 No
Yes <Missing> Yes 1 No
No <Missing> Yes 5 No
No <Missing> Yes 3 No
Yes <Missing> No 5 Yes
Yes <Missing> No 5 Yes
Yes <Missing> Yes 1 No
Yes <Missing> Yes 1 No
No <Missing> Yes 2 No
CHN-11/220 26/F/ASIAN No <Missing> Yes 3 No
Yes <Missing> Yes 1 No
Yes <Missing> Yes 1 No
No <Missing> Yes 4 No
CHN-11/263 34/F/ASIAN No <Missing> Yes 5 Yes
No <Missing> Yes 6 Yes
No <Missing> Yes 3 No
No <Missing> Yes 6 No
No <Missing> Yes 2 Yes
No <Missing> Yes 3 Yes
No <Missing> Yes 2 Yes
CHN-11/38 25/F/WHITE Yes <Missing> No 2 No
CHN-13/102 37/M/ASIAN Yes <Missing> Yes 1 No
No <Missing> No 2 No
No <Missing> No 3 No
Yes <Missing> Yes 1 Yes
\s\nACTARM: <Missing>
————————————————————————————————————————————————————————————
Action
Taken
Center/Patients ID Age/Sex/Race (2)
————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN 5
7
2
BRA-11/9 40/M/ASIAN 3
2
6
6
2
3
6
2
CAN-1/341 43/F/ASIAN 2
2
6
1
3
2
2
2
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN 7
2
1
3
2
6
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN 1
6
2
2
3
3
6
6
3
CHN-11/220 26/F/ASIAN 3
6
6
3
CHN-11/263 34/F/ASIAN 1
6
2
2
6
2
2
CHN-11/38 25/F/WHITE 2
CHN-13/102 37/M/ASIAN 6
2
3
6
ael02 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 D.1.1.4.2 28APR2019 108 67
dcd C.1.1.1.3 28APR2019 437 39
dcd A.1.1.1.2 28APR2019 1007 68
CHN-14/1 27/F/ASIAN dcd D.1.1.4.2 07MAY2019 193 525
dcd A.1.1.1.1 07MAY2019 194 414
dcd A.1.1.1.2 07MAY2019 258 657
dcd C.1.1.1.3 07MAY2019 367 645
dcd C.2.1.2.1 07MAY2019 371 214
dcd B.2.2.3.1 07MAY2019 385 20
dcd B.1.1.1.1 07MAY2019 517 280
\s\nACTARM: A: Drug X
———————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by
Extreme Study Outcome Treatment
Center/Patients ID Age/Sex/Race Serious Intensity Drug (1) for AE
———————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN No MODERATE No 5 No
No SEVERE Yes 3 No
Yes MODERATE No 3 Yes
CHN-14/1 27/F/ASIAN No MODERATE No 3 Yes
No MILD No 5 Yes
Yes MODERATE No 2 No
No SEVERE Yes 3 Yes
No MODERATE Yes 6 Yes
Yes MILD No 6 Yes
Yes SEVERE Yes 1 No
\s\nACTARM: A: Drug X
————————————————————————————————————————————————————————————
Action
Taken
Center/Patients ID Age/Sex/Race (2)
————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN 5
7
2
CHN-14/1 27/F/ASIAN 3
7
2
2
6
2
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.2.1.2.1 23MAY2019 253 72
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.1.1.1.1 23MAY2019 628 265
dcd C.2.1.2.1 23MAY2019 750 128
dcd A.1.1.1.2 23MAY2019 769 73
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN dcd C.1.1.1.3 09APR2019 253 202
dcd B.2.1.2.1 09APR2019 311 297
\s\nACTARM: B: Placebo
———————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by
Extreme Study Outcome Treatment
Center/Patients ID Age/Sex/Race Serious Intensity Drug (1) for AE
———————————————————————————————————————————————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN Yes MODERATE No 5 Yes
No MODERATE No 5 Yes
Yes SEVERE Yes 1 No
Yes MODERATE No 6 No
Yes MODERATE No 3 Yes
No MILD No 2 Yes
No MODERATE Yes 2 No
Yes MODERATE No 5 No
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN No SEVERE Yes 3 No
No MODERATE No 2 No
\s\nACTARM: B: Placebo
————————————————————————————————————————————————————————————
Action
Taken
Center/Patients ID Age/Sex/Race (2)
————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN 2
2
6
1
3
2
2
2
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN 7
2
\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 D.1.1.4.2 25MAR2019 342 700
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
dcd C.2.1.2.1 25MAR2019 744 185
dcd C.2.1.2.1 25MAR2019 808 166
dcd B.2.1.2.1 25MAR2019 970 15
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN dcd B.2.1.2.1 28APR2019 31 678
dcd D.1.1.1.1 28APR2019 92 254
\s\nACTARM: C: Combination
———————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by
Extreme Study Outcome Treatment
Center/Patients ID Age/Sex/Race Serious Intensity Drug (1) for AE
———————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN No MODERATE No 2 No
Yes MILD No 5 No
Yes SEVERE Yes 1 No
Yes SEVERE Yes 1 No
Yes MILD No 5 Yes
No MODERATE Yes 4 No
No MODERATE Yes 3 No
No MODERATE No 3 No
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN No MODERATE No 6 No
Yes SEVERE Yes 1 No
\s\nACTARM: C: Combination
————————————————————————————————————————————————————————————
Action
Taken
Center/Patients ID Age/Sex/Race (2)
————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN 3
2
6
6
2
3
6
2
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN 1
6
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ael02 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 D.1.1.4.2 28APR2019 108 67
dcd C.1.1.1.3 28APR2019 437 39
dcd A.1.1.1.2 28APR2019 1007 68
CHN-14/1 27/F/ASIAN dcd D.1.1.4.2 07MAY2019 193 525
dcd A.1.1.1.1 07MAY2019 194 414
dcd A.1.1.1.2 07MAY2019 258 657
dcd C.1.1.1.3 07MAY2019 367 645
dcd C.2.1.2.1 07MAY2019 371 214
dcd B.2.2.3.1 07MAY2019 385 20
dcd B.1.1.1.1 07MAY2019 517 280
\s\nACTARM: A: Drug X
———————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by
Extreme Study Outcome Treatment
Center/Patients ID Age/Sex/Race Serious Intensity Drug (1) for AE
———————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN No MODERATE No 5 No
No SEVERE Yes 3 No
Yes MODERATE No 3 Yes
CHN-14/1 27/F/ASIAN No MODERATE No 3 Yes
No MILD No 5 Yes
Yes MODERATE No 2 No
No SEVERE Yes 3 Yes
No MODERATE Yes 6 Yes
Yes MILD No 6 Yes
Yes SEVERE Yes 1 No
\s\nACTARM: A: Drug X
————————————————————————————————————————————————————————————
Action
Taken
Center/Patients ID Age/Sex/Race (2)
————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN 5
7
2
CHN-14/1 27/F/ASIAN 3
7
2
2
6
2
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.2.1.2.1 23MAY2019 253 72
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.1.1.1.1 23MAY2019 628 265
dcd C.2.1.2.1 23MAY2019 750 128
dcd A.1.1.1.2 23MAY2019 769 73
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN dcd C.1.1.1.3 09APR2019 253 202
dcd B.2.1.2.1 09APR2019 311 297
\s\nACTARM: B: Placebo
———————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by
Extreme Study Outcome Treatment
Center/Patients ID Age/Sex/Race Serious Intensity Drug (1) for AE
———————————————————————————————————————————————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN Yes MODERATE No 5 Yes
No MODERATE No 5 Yes
Yes SEVERE Yes 1 No
Yes MODERATE No 6 No
Yes MODERATE No 3 Yes
No MILD No 2 Yes
No MODERATE Yes 2 No
Yes MODERATE No 5 No
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN No SEVERE Yes 3 No
No MODERATE No 2 No
\s\nACTARM: B: Placebo
————————————————————————————————————————————————————————————
Action
Taken
Center/Patients ID Age/Sex/Race (2)
————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN 2
2
6
1
3
2
2
2
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN 7
2
\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 D.1.1.4.2 25MAR2019 342 700
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
dcd C.2.1.2.1 25MAR2019 744 185
dcd C.2.1.2.1 25MAR2019 808 166
dcd B.2.1.2.1 25MAR2019 970 15
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN dcd B.2.1.2.1 28APR2019 31 678
dcd D.1.1.1.1 28APR2019 92 254
\s\nACTARM: C: Combination
———————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by
Extreme Study Outcome Treatment
Center/Patients ID Age/Sex/Race Serious Intensity Drug (1) for AE
———————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN No MODERATE No 2 No
Yes MILD No 5 No
Yes SEVERE Yes 1 No
Yes SEVERE Yes 1 No
Yes MILD No 5 Yes
No MODERATE Yes 4 No
No MODERATE Yes 3 No
No MODERATE No 3 No
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN No MODERATE No 6 No
Yes SEVERE Yes 1 No
\s\nACTARM: C: Combination
————————————————————————————————————————————————————————————
Action
Taken
Center/Patients ID Age/Sex/Race (2)
————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN 3
2
6
6
2
3
6
2
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN 1
6
ael02 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 108 67
<Missing> 28APR2019 437 39
<Missing> 28APR2019 1007 68
BRA-11/9 40/M/ASIAN <Missing> 25MAR2019 342 700
<Missing> 25MAR2019 441 53
<Missing> 25MAR2019 445 598
<Missing> 25MAR2019 644 42
<Missing> 25MAR2019 669 100
<Missing> 25MAR2019 744 185
<Missing> 25MAR2019 808 166
<Missing> 25MAR2019 970 15
CAN-1/341 43/F/ASIAN <Missing> 23MAY2019 57 326
<Missing> 23MAY2019 253 72
<Missing> 23MAY2019 434 409
<Missing> 23MAY2019 454 506
<Missing> 23MAY2019 523 391
<Missing> 23MAY2019 628 265
<Missing> 23MAY2019 750 128
<Missing> 23MAY2019 769 73
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN <Missing> 09APR2019 253 202
<Missing> 09APR2019 311 297
<Missing> 09APR2019 400 424
<Missing> 09APR2019 449 300
<Missing> 09APR2019 685 309
<Missing> 09APR2019 803 129
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN <Missing> 28APR2019 31 678
<Missing> 28APR2019 92 254
<Missing> 28APR2019 239 213
<Missing> 28APR2019 365 353
<Missing> 28APR2019 449 516
<Missing> 28APR2019 593 51
<Missing> 28APR2019 671 32
<Missing> 28APR2019 937 36
<Missing> 28APR2019 996 9
CHN-11/220 26/F/ASIAN <Missing> 01MAR2019 406 422
<Missing> 01MAR2019 876 175
<Missing> 01MAR2019 910 162
<Missing> 01MAR2019 979 118
CHN-11/263 34/F/ASIAN <Missing> 03APR2019 140 43
<Missing> 03APR2019 263 147
<Missing> 03APR2019 524 519
<Missing> 03APR2019 714 163
<Missing> 03APR2019 768 277
<Missing> 03APR2019 876 194
<Missing> 03APR2019 955 106
CHN-11/38 25/F/WHITE <Missing> 17JUN2019 523 536
CHN-13/102 37/M/ASIAN <Missing> 23MAR2019 34 555
<Missing> 23MAR2019 55 73
<Missing> 23MAR2019 57 57
<Missing> 23MAR2019 65 400
\s\nACTARM: <Missing>
———————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by
Extreme Study Outcome Treatment
Center/Patients ID Age/Sex/Race Serious Intensity Drug (1) for AE
———————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN No <Missing> No 5 No
No <Missing> Yes 3 No
Yes <Missing> No 3 Yes
BRA-11/9 40/M/ASIAN No <Missing> No 2 No
Yes <Missing> No 5 No
Yes <Missing> Yes 1 No
Yes <Missing> Yes 1 No
Yes <Missing> No 5 Yes
No <Missing> Yes 4 No
No <Missing> Yes 3 No
No <Missing> No 3 No
CAN-1/341 43/F/ASIAN Yes <Missing> No 5 Yes
No <Missing> No 5 Yes
Yes <Missing> Yes 1 No
Yes <Missing> No 6 No
Yes <Missing> No 3 Yes
No <Missing> No 2 Yes
No <Missing> Yes 2 No
Yes <Missing> No 5 No
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN No <Missing> Yes 3 No
No <Missing> No 2 No
No <Missing> Yes 3 No
No <Missing> Yes 5 No
Yes <Missing> No 6 Yes
Yes <Missing> No 6 No
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN No <Missing> No 6 No
Yes <Missing> Yes 1 No
No <Missing> Yes 5 No
No <Missing> Yes 3 No
Yes <Missing> No 5 Yes
Yes <Missing> No 5 Yes
Yes <Missing> Yes 1 No
Yes <Missing> Yes 1 No
No <Missing> Yes 2 No
CHN-11/220 26/F/ASIAN No <Missing> Yes 3 No
Yes <Missing> Yes 1 No
Yes <Missing> Yes 1 No
No <Missing> Yes 4 No
CHN-11/263 34/F/ASIAN No <Missing> Yes 5 Yes
No <Missing> Yes 6 Yes
No <Missing> Yes 3 No
No <Missing> Yes 6 No
No <Missing> Yes 2 Yes
No <Missing> Yes 3 Yes
No <Missing> Yes 2 Yes
CHN-11/38 25/F/WHITE Yes <Missing> No 2 No
CHN-13/102 37/M/ASIAN Yes <Missing> Yes 1 No
No <Missing> No 2 No
No <Missing> No 3 No
Yes <Missing> Yes 1 Yes
\s\nACTARM: <Missing>
————————————————————————————————————————————————————————————
Action
Taken
Center/Patients ID Age/Sex/Race (2)
————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN 5
7
2
BRA-11/9 40/M/ASIAN 3
2
6
6
2
3
6
2
CAN-1/341 43/F/ASIAN 2
2
6
1
3
2
2
2
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN 7
2
1
3
2
6
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN 1
6
2
2
3
3
6
6
3
CHN-11/220 26/F/ASIAN 3
6
6
3
CHN-11/263 34/F/ASIAN 1
6
2
2
6
2
2
CHN-11/38 25/F/WHITE 2
CHN-13/102 37/M/ASIAN 6
2
3
6
ael02 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 D.1.1.4.2 28APR2019 108 67
dcd C.1.1.1.3 28APR2019 437 39
dcd A.1.1.1.2 28APR2019 1007 68
CHN-14/1 27/F/ASIAN dcd D.1.1.4.2 07MAY2019 193 525
dcd A.1.1.1.1 07MAY2019 194 414
dcd A.1.1.1.2 07MAY2019 258 657
dcd C.1.1.1.3 07MAY2019 367 645
dcd C.2.1.2.1 07MAY2019 371 214
dcd B.2.2.3.1 07MAY2019 385 20
dcd B.1.1.1.1 07MAY2019 517 280
\s\nACTARM: A: Drug X
———————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by
Extreme Study Outcome Treatment
Center/Patients ID Age/Sex/Race Serious Intensity Drug (1) for AE
———————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN No MODERATE No 5 No
No SEVERE Yes 3 No
Yes MODERATE No 3 Yes
CHN-14/1 27/F/ASIAN No MODERATE No 3 Yes
No MILD No 5 Yes
Yes MODERATE No 2 No
No SEVERE Yes 3 Yes
No MODERATE Yes 6 Yes
Yes MILD No 6 Yes
Yes SEVERE Yes 1 No
\s\nACTARM: A: Drug X
————————————————————————————————————————————————————————————
Action
Taken
Center/Patients ID Age/Sex/Race (2)
————————————————————————————————————————————————————————————
BRA-11/50 26/M/BLACK OR AFRICAN AMERICAN 5
7
2
CHN-14/1 27/F/ASIAN 3
7
2
2
6
2
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.2.1.2.1 23MAY2019 253 72
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.1.1.1.1 23MAY2019 628 265
dcd C.2.1.2.1 23MAY2019 750 128
dcd A.1.1.1.2 23MAY2019 769 73
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN dcd C.1.1.1.3 09APR2019 253 202
dcd B.2.1.2.1 09APR2019 311 297
\s\nACTARM: B: Placebo
———————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by
Extreme Study Outcome Treatment
Center/Patients ID Age/Sex/Race Serious Intensity Drug (1) for AE
———————————————————————————————————————————————————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN Yes MODERATE No 5 Yes
No MODERATE No 5 Yes
Yes SEVERE Yes 1 No
Yes MODERATE No 6 No
Yes MODERATE No 3 Yes
No MILD No 2 Yes
No MODERATE Yes 2 No
Yes MODERATE No 5 No
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN No SEVERE Yes 3 No
No MODERATE No 2 No
\s\nACTARM: B: Placebo
————————————————————————————————————————————————————————————
Action
Taken
Center/Patients ID Age/Sex/Race (2)
————————————————————————————————————————————————————————————
CAN-1/341 43/F/ASIAN 2
2
6
1
3
2
2
2
CHN-1/227 26/F/BLACK OR AFRICAN AMERICAN 7
2
\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 D.1.1.4.2 25MAR2019 342 700
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
dcd C.2.1.2.1 25MAR2019 744 185
dcd C.2.1.2.1 25MAR2019 808 166
dcd B.2.1.2.1 25MAR2019 970 15
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN dcd B.2.1.2.1 28APR2019 31 678
dcd D.1.1.1.1 28APR2019 92 254
\s\nACTARM: C: Combination
———————————————————————————————————————————————————————————————————————————————————————————————————————————
Most Caused by
Extreme Study Outcome Treatment
Center/Patients ID Age/Sex/Race Serious Intensity Drug (1) for AE
———————————————————————————————————————————————————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN No MODERATE No 2 No
Yes MILD No 5 No
Yes SEVERE Yes 1 No
Yes SEVERE Yes 1 No
Yes MILD No 5 Yes
No MODERATE Yes 4 No
No MODERATE Yes 3 No
No MODERATE No 3 No
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN No MODERATE No 6 No
Yes SEVERE Yes 1 No
\s\nACTARM: C: Combination
————————————————————————————————————————————————————————————
Action
Taken
Center/Patients ID Age/Sex/Race (2)
————————————————————————————————————————————————————————————
BRA-11/9 40/M/ASIAN 3
2
6
6
2
3
6
2
CHN-1/64 34/F/BLACK OR AFRICAN AMERICAN 1
6
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