Shannon Pileggi & Daniel D. Sjoberg
Introduction
About adverse events
First adverse event tables
Modified adverse event tables
Other convenience functions
Exporting options
This presentation is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License (CC BY-SA4.0).
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Introduction
About adverse events
First adverse event tables
Modified adverse event tables
Other convenience functions
Exporting options
patient_id | trt | system_organ_class | adverse_event | grade | drug_attribution |
---|---|---|---|---|---|
ID 1 | Drug B | Blood and lymphatic system disorders | Anaemia | 4 | Unrelated |
ID 1 | Drug B | Blood and lymphatic system disorders | Increased tendency to bruise | 5 | Unrelated |
ID 1 | Drug B | Blood and lymphatic system disorders | Increased tendency to bruise | 4 | Unlikely |
ID 1 | Drug B | Blood and lymphatic system disorders | Thrombocytopenia | 1 | Probably |
ID 1 | Drug B | Blood and lymphatic system disorders | Thrombocytopenia | 3 | Definite |
An adverse event (AE) is a medical issue that occurs during the course of treatment or observation.
AEs are classified according to a hierarchy, and we typically report lower level terms within a system organ class.
AEs also record severity / grade and likelihood of attribution to treatment.
patient_id | trt | system_organ_class | adverse_event | grade | drug_attribution |
---|---|---|---|---|---|
ID 1 | Drug B | Blood and lymphatic system disorders | Anaemia | 4 | Unrelated |
ID 1 | Drug B | Blood and lymphatic system disorders | Increased tendency to bruise | 5 | Unrelated |
ID 1 | Drug B | Blood and lymphatic system disorders | Increased tendency to bruise | 4 | Unlikely |
ID 1 | Drug B | Blood and lymphatic system disorders | Thrombocytopenia | 1 | Probably |
ID 1 | Drug B | Blood and lymphatic system disorders | Thrombocytopenia | 3 | Definite |
Subjects experience multiple adverse events.
Not all enrolled subjects experience an adverse event.
The percent of subjects experiencing specific AEs is of interest; typically AEs are counted by maximum grade per event per subject.
Multiple AE tables are often required (treatment emergent AEs, AEs on specific treatment cycles, serious AEs, etc.).
patient_id | system_organ_class | adverse_event | grade |
---|---|---|---|
ID 1 | Blood and lymphatic system disorders | Anaemia | 4 |
ID 1 | Blood and lymphatic system disorders | Increased tendency to bruise | 5 |
ID 1 | Blood and lymphatic system disorders | Increased tendency to bruise | 4 |
ID 1 | Blood and lymphatic system disorders | Thrombocytopenia | 1 |
ID 1 | Blood and lymphatic system disorders | Thrombocytopenia | 3 |
Patient ID | System Organ Class | Adverse Event | Grade |
---|---|---|---|
Term 1 | |||
ID 1 | Blood and lymphatic system disorders | Anaemia | 4 |
Term 2 | |||
ID 1 | Blood and lymphatic system disorders | Increased tendency to bruise | 5 |
ID 1 | Blood and lymphatic system disorders | Increased tendency to bruise | 4 |
Term 3 | |||
ID 1 | Blood and lymphatic system disorders | Thrombocytopenia | 1 |
ID 1 | Blood and lymphatic system disorders | Thrombocytopenia | 3 |
Patient ID | System Organ Class | Adverse Event | Grade |
---|---|---|---|
Term 1 | |||
ID 1 | Blood and lymphatic system disorders | Anaemia | 4 |
Term 2 | |||
ID 1 | Blood and lymphatic system disorders | Increased tendency to bruise | 5 |
ID 1 | Blood and lymphatic system disorders | Increased tendency to bruise | 4 |
Term 3 | |||
ID 1 | Blood and lymphatic system disorders | Thrombocytopenia | 1 |
ID 1 | Blood and lymphatic system disorders | Thrombocytopenia | 3 |
Similar logic applies when counting by severity (e.g. mild, moderate, severe) - if stored as a factor, the highest factor level is retained (severe).
Introduction
About adverse events
First adverse event tables
Modified adverse event tables
Other convenience functions
Exporting options
df_adverse_events
100 unique subjects
1 row per subject
patient_id | trt | system_organ_class | adverse_event | grade | drug_attribution | any_complication | grade3_complication |
---|---|---|---|---|---|---|---|
ID 1 | Drug B | Blood and lymphatic system disorders | Anaemia | 4 | Unrelated | TRUE | TRUE |
ID 1 | Drug B | Blood and lymphatic system disorders | Increased tendency to bruise | 5 | Unrelated | TRUE | TRUE |
ID 1 | Drug B | Blood and lymphatic system disorders | Increased tendency to bruise | 4 | Unlikely | TRUE | TRUE |
ID 1 | Drug B | Blood and lymphatic system disorders | Thrombocytopenia | 1 | Probably | TRUE | FALSE |
ID 1 | Drug B | Blood and lymphatic system disorders | Thrombocytopenia | 3 | Definite | TRUE | TRUE |
ID 1 | Drug B | Gastrointestinal disorders | Intestinal dilatation | 2 | Definite | TRUE | FALSE |
df_patient_characteristics
10 unique subjects
multiple rows per subject
patient_id | trt | age | marker | status | discontinued | off_trt_ae |
---|---|---|---|---|---|---|
ID 1 | Drug B | 28 | 4.807148 | Adverse Event | Yes | Intestinal dilatation |
ID 2 | Drug B | 47 | 7.714544 | Completed Study | No | NA |
ID 3 | Drug B | 39 | 6.449793 | Completed Study | No | NA |
ID 4 | Drug B | 45 | 6.319944 | Subject Withdrew | Yes | NA |
ID 5 | Drug B | 58 | 5.785283 | Physician Decision | Yes | NA |
ID 6 | Drug A | 42 | 5.630501 | Completed Study | No | NA |
A variable label is an attribute of a variable in a data frame.
Where applicable, variable labels (not variable names) are printed in {gtsummary} and {gtreg} tables.
The example data in {gtreg} comes with variable labels; you can also create your own via labelled::set_variable_labels()
.
Adverse Event | 1 | 2 | 3 | 4 | 5 |
---|---|---|---|---|---|
Blood and lymphatic system disorders | 8 | 6 | 11 | 12 | 13 |
Anaemia | 1 | — | 3 | 3 | 3 |
Increased tendency to bruise | — | — | 2 | 5 | 2 |
Iron deficiency anaemia | 4 | 3 | — | 3 | 3 |
Thrombocytopenia | 3 | 3 | 6 | 1 | 5 |
Gastrointestinal disorders | 14 | 9 | 7 | 11 | 9 |
Difficult digestion | 1 | — | — | 3 | 1 |
Intestinal dilatation | 3 | 1 | — | — | 1 |
Myochosis | 1 | 4 | 3 | 2 | 3 |
Non-erosive reflux disease | 5 | — | — | 4 | 3 |
Pancreatic enzyme abnormality | 4 | 4 | 4 | 2 | 1 |
adverse_event | system_organ_class | grade |
---|---|---|
Anaemia | Blood and lymphatic system disorders | 4 |
Increased tendency to bruise | Blood and lymphatic system disorders | 5 |
Increased tendency to bruise | Blood and lymphatic system disorders | 4 |
Thrombocytopenia | Blood and lymphatic system disorders | 1 |
Thrombocytopenia | Blood and lymphatic system disorders | 3 |
Intestinal dilatation | Gastrointestinal disorders | 2 |
Intestinal dilatation | Gastrointestinal disorders | 1 |
Myochosis | Gastrointestinal disorders | 3 |
Myochosis | Gastrointestinal disorders | 5 |
Non-erosive reflux disease | Gastrointestinal disorders | 5 |
Adverse Event | N = 10 | ||||
---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | |
Blood and lymphatic system disorders | — | 1 (10) | — | 2 (20) | 7 (70) |
Anaemia | — | — | 2 (20) | 2 (20) | 3 (30) |
Increased tendency to bruise | — | — | — | 4 (40) | 2 (20) |
Iron deficiency anaemia | 1 (10) | 2 (20) | — | 2 (20) | 2 (20) |
Thrombocytopenia | — | 1 (10) | 3 (30) | 1 (10) | 4 (40) |
Gastrointestinal disorders | — | — | — | 4 (40) | 6 (60) |
Difficult digestion | 1 (10) | — | — | 3 (30) | 1 (10) |
Intestinal dilatation | 2 (20) | 1 (10) | — | — | 1 (10) |
Myochosis | — | 3 (30) | 1 (10) | 1 (10) | 3 (30) |
Non-erosive reflux disease | 4 (40) | — | — | 3 (30) | 3 (30) |
Pancreatic enzyme abnormality | 2 (20) | 1 (10) | 2 (20) | 2 (20) | 1 (10) |
patient_id | adverse_event | system_organ_class | grade |
---|---|---|---|
ID 1 | Anaemia | Blood and lymphatic system disorders | 4 |
ID 1 | Increased tendency to bruise | Blood and lymphatic system disorders | 5 |
ID 1 | Increased tendency to bruise | Blood and lymphatic system disorders | 4 |
ID 1 | Thrombocytopenia | Blood and lymphatic system disorders | 1 |
ID 1 | Thrombocytopenia | Blood and lymphatic system disorders | 3 |
ID 1 | Intestinal dilatation | Gastrointestinal disorders | 2 |
ID 1 | Intestinal dilatation | Gastrointestinal disorders | 1 |
ID 1 | Myochosis | Gastrointestinal disorders | 3 |
ID 1 | Myochosis | Gastrointestinal disorders | 5 |
ID 1 | Non-erosive reflux disease | Gastrointestinal disorders | 5 |
Count AEs per subject by maximum grade.
Supply id_df
to achieve subject denominator.
Adverse Event | N = 100 | ||||
---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | |
Blood and lymphatic system disorders | — | 1 (1.0) | — | 2 (2.0) | 7 (7.0) |
Anaemia | — | — | 2 (2.0) | 2 (2.0) | 3 (3.0) |
Increased tendency to bruise | — | — | — | 4 (4.0) | 2 (2.0) |
Iron deficiency anaemia | 1 (1.0) | 2 (2.0) | — | 2 (2.0) | 2 (2.0) |
Thrombocytopenia | — | 1 (1.0) | 3 (3.0) | 1 (1.0) | 4 (4.0) |
Gastrointestinal disorders | — | — | — | 4 (4.0) | 6 (6.0) |
Difficult digestion | 1 (1.0) | — | — | 3 (3.0) | 1 (1.0) |
Intestinal dilatation | 2 (2.0) | 1 (1.0) | — | — | 1 (1.0) |
Myochosis | — | 3 (3.0) | 1 (1.0) | 1 (1.0) | 3 (3.0) |
Non-erosive reflux disease | 4 (4.0) | — | — | 3 (3.0) | 3 (3.0) |
Pancreatic enzyme abnormality | 2 (2.0) | 1 (1.0) | 2 (2.0) | 2 (2.0) | 1 (1.0) |
df_adverse_events
patient_id | adverse_event | system_organ_class | grade |
---|---|---|---|
ID 1 | Anaemia | Blood and lymphatic system disorders | 4 |
ID 1 | Increased tendency to bruise | Blood and lymphatic system disorders | 5 |
ID 1 | Increased tendency to bruise | Blood and lymphatic system disorders | 4 |
ID 1 | Thrombocytopenia | Blood and lymphatic system disorders | 1 |
ID 1 | Thrombocytopenia | Blood and lymphatic system disorders | 3 |
df_patient_characteristics
patient_id | trt |
---|---|
ID 1 | Drug B |
ID 2 | Drug B |
ID 3 | Drug B |
ID 4 | Drug B |
ID 5 | Drug B |
Count dichotomous AE attributes via include
.
Supply id_df
to achieve subject denominator.
Adverse Event | N = 100 | |
---|---|---|
Any Grade Complication | Grade 3+ Complication | |
Blood and lymphatic system disorders | 10 (10) | 9 (9.0) |
Anaemia | 7 (7.0) | 7 (7.0) |
Increased tendency to bruise | 6 (6.0) | 6 (6.0) |
Iron deficiency anaemia | 7 (7.0) | 4 (4.0) |
Thrombocytopenia | 9 (9.0) | 8 (8.0) |
Gastrointestinal disorders | 10 (10) | 10 (10) |
Difficult digestion | 5 (5.0) | 4 (4.0) |
Intestinal dilatation | 4 (4.0) | 1 (1.0) |
Myochosis | 8 (8.0) | 5 (5.0) |
Non-erosive reflux disease | 10 (10) | 6 (6.0) |
Pancreatic enzyme abnormality | 8 (8.0) | 5 (5.0) |
df_adverse_events
patient_id | adverse_event | system_organ_class | any_complication | grade3_complication |
---|---|---|---|---|
ID 1 | Anaemia | Blood and lymphatic system disorders | TRUE | TRUE |
ID 1 | Increased tendency to bruise | Blood and lymphatic system disorders | TRUE | TRUE |
ID 1 | Increased tendency to bruise | Blood and lymphatic system disorders | TRUE | TRUE |
ID 1 | Thrombocytopenia | Blood and lymphatic system disorders | TRUE | FALSE |
ID 1 | Thrombocytopenia | Blood and lymphatic system disorders | TRUE | TRUE |
df_patient_characteristics
patient_id | trt |
---|---|
ID 1 | Drug B |
ID 2 | Drug B |
ID 3 | Drug B |
ID 4 | Drug B |
ID 5 | Drug B |
Introduction
About adverse events
First adverse event tables
Modified adverse event tables
Other convenience functions
Exporting options
Adverse Event | Drug A, N = 44 | Drug B, N = 56 | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | |
Blood and lymphatic system disorders | — | 1 (2.3) | — | 1 (2.3) | 1 (2.3) | — | — | — | 1 (1.8) | 6 (11) |
Anaemia | — | — | 1 (2.3) | 1 (2.3) | — | — | — | 1 (1.8) | 1 (1.8) | 3 (5.4) |
Increased tendency to bruise | — | — | — | 1 (2.3) | — | — | — | — | 3 (5.4) | 2 (3.6) |
Iron deficiency anaemia | — | — | — | 1 (2.3) | 1 (2.3) | 1 (1.8) | 2 (3.6) | — | 1 (1.8) | 1 (1.8) |
Thrombocytopenia | — | 1 (2.3) | — | 1 (2.3) | — | — | — | 3 (5.4) | — | 4 (7.1) |
Gastrointestinal disorders | — | — | — | 2 (4.5) | 1 (2.3) | — | — | — | 2 (3.6) | 5 (8.9) |
Difficult digestion | — | — | — | 3 (6.8) | — | 1 (1.8) | — | — | — | 1 (1.8) |
Intestinal dilatation | 1 (2.3) | — | — | — | — | 1 (1.8) | 1 (1.8) | — | — | 1 (1.8) |
Myochosis | — | 2 (4.5) | 1 (2.3) | — | — | — | 1 (1.8) | — | 1 (1.8) | 3 (5.4) |
Non-erosive reflux disease | 3 (6.8) | — | — | — | — | 1 (1.8) | — | — | 3 (5.4) | 3 (5.4) |
Pancreatic enzyme abnormality | — | — | 1 (2.3) | 1 (2.3) | 1 (2.3) | 2 (3.6) | 1 (1.8) | 1 (1.8) | 1 (1.8) | — |
df_adverse_events
patient_id | trt | adverse_event | system_organ_class | grade |
---|---|---|---|---|
ID 1 | Drug B | Anaemia | Blood and lymphatic system disorders | 4 |
ID 1 | Drug B | Increased tendency to bruise | Blood and lymphatic system disorders | 5 |
ID 1 | Drug B | Increased tendency to bruise | Blood and lymphatic system disorders | 4 |
ID 1 | Drug B | Thrombocytopenia | Blood and lymphatic system disorders | 1 |
ID 1 | Drug B | Thrombocytopenia | Blood and lymphatic system disorders | 3 |
df_patient_characteristics
patient_id | trt |
---|---|
ID 1 | Drug B |
ID 2 | Drug B |
ID 3 | Drug B |
ID 4 | Drug B |
ID 5 | Drug B |
See documentation for more add_overall()
functionality.
Adverse Event | Drug A, N = 44 | Drug B, N = 56 | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | Overall | 1 | 2 | 3 | 4 | 5 | Overall | |
Blood and lymphatic system disorders | — | 1 (2.3) | — | 1 (2.3) | 1 (2.3) | 3 (6.8) | — | — | — | 1 (1.8) | 6 (11) | 7 (12) |
Anaemia | — | — | 1 (2.3) | 1 (2.3) | — | 2 (4.5) | — | — | 1 (1.8) | 1 (1.8) | 3 (5.4) | 5 (8.9) |
Increased tendency to bruise | — | — | — | 1 (2.3) | — | 1 (2.3) | — | — | — | 3 (5.4) | 2 (3.6) | 5 (8.9) |
Iron deficiency anaemia | — | — | — | 1 (2.3) | 1 (2.3) | 2 (4.5) | 1 (1.8) | 2 (3.6) | — | 1 (1.8) | 1 (1.8) | 5 (8.9) |
Thrombocytopenia | — | 1 (2.3) | — | 1 (2.3) | — | 2 (4.5) | — | — | 3 (5.4) | — | 4 (7.1) | 7 (12) |
Gastrointestinal disorders | — | — | — | 2 (4.5) | 1 (2.3) | 3 (6.8) | — | — | — | 2 (3.6) | 5 (8.9) | 7 (12) |
Difficult digestion | — | — | — | 3 (6.8) | — | 3 (6.8) | 1 (1.8) | — | — | — | 1 (1.8) | 2 (3.6) |
Intestinal dilatation | 1 (2.3) | — | — | — | — | 1 (2.3) | 1 (1.8) | 1 (1.8) | — | — | 1 (1.8) | 3 (5.4) |
Myochosis | — | 2 (4.5) | 1 (2.3) | — | — | 3 (6.8) | — | 1 (1.8) | — | 1 (1.8) | 3 (5.4) | 5 (8.9) |
Non-erosive reflux disease | 3 (6.8) | — | — | — | — | 3 (6.8) | 1 (1.8) | — | — | 3 (5.4) | 3 (5.4) | 7 (12) |
Pancreatic enzyme abnormality | — | — | 1 (2.3) | 1 (2.3) | 1 (2.3) | 3 (6.8) | 2 (3.6) | 1 (1.8) | 1 (1.8) | 1 (1.8) | — | 5 (8.9) |
df_adverse_events
patient_id | trt | adverse_event | system_organ_class | grade |
---|---|---|---|---|
ID 1 | Drug B | Anaemia | Blood and lymphatic system disorders | 4 |
ID 1 | Drug B | Increased tendency to bruise | Blood and lymphatic system disorders | 5 |
ID 1 | Drug B | Increased tendency to bruise | Blood and lymphatic system disorders | 4 |
ID 1 | Drug B | Thrombocytopenia | Blood and lymphatic system disorders | 1 |
ID 1 | Drug B | Thrombocytopenia | Blood and lymphatic system disorders | 3 |
df_patient_characteristics
patient_id | trt |
---|---|
ID 1 | Drug B |
ID 2 | Drug B |
ID 3 | Drug B |
ID 4 | Drug B |
ID 5 | Drug B |
df_adverse_events |>
tbl_ae(
id = patient_id,
id_df = df_patient_characteristics,
strata = trt,
ae = adverse_event,
soc = system_organ_class,
by = grade
) |>
add_overall(across = 'by') |>
modify_header(
all_ae_cols() ~ "**Grade {by}**"
) %>%
modify_spanning_header(
all_ae_cols(TRUE, TRUE) ~ "**{strata}** \nN = {n}"
) |>
bold_labels()
Adverse Event |
Drug A N = 44 |
Drug B N = 56 |
||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Overall | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Overall | |
Blood and lymphatic system disorders | — | 1 (2.3) | — | 1 (2.3) | 1 (2.3) | 3 (6.8) | — | — | — | 1 (1.8) | 6 (11) | 7 (12) |
Anaemia | — | — | 1 (2.3) | 1 (2.3) | — | 2 (4.5) | — | — | 1 (1.8) | 1 (1.8) | 3 (5.4) | 5 (8.9) |
Increased tendency to bruise | — | — | — | 1 (2.3) | — | 1 (2.3) | — | — | — | 3 (5.4) | 2 (3.6) | 5 (8.9) |
Iron deficiency anaemia | — | — | — | 1 (2.3) | 1 (2.3) | 2 (4.5) | 1 (1.8) | 2 (3.6) | — | 1 (1.8) | 1 (1.8) | 5 (8.9) |
Thrombocytopenia | — | 1 (2.3) | — | 1 (2.3) | — | 2 (4.5) | — | — | 3 (5.4) | — | 4 (7.1) | 7 (12) |
Gastrointestinal disorders | — | — | — | 2 (4.5) | 1 (2.3) | 3 (6.8) | — | — | — | 2 (3.6) | 5 (8.9) | 7 (12) |
Difficult digestion | — | — | — | 3 (6.8) | — | 3 (6.8) | 1 (1.8) | — | — | — | 1 (1.8) | 2 (3.6) |
Intestinal dilatation | 1 (2.3) | — | — | — | — | 1 (2.3) | 1 (1.8) | 1 (1.8) | — | — | 1 (1.8) | 3 (5.4) |
Myochosis | — | 2 (4.5) | 1 (2.3) | — | — | 3 (6.8) | — | 1 (1.8) | — | 1 (1.8) | 3 (5.4) | 5 (8.9) |
Non-erosive reflux disease | 3 (6.8) | — | — | — | — | 3 (6.8) | 1 (1.8) | — | — | 3 (5.4) | 3 (5.4) | 7 (12) |
Pancreatic enzyme abnormality | — | — | 1 (2.3) | 1 (2.3) | 1 (2.3) | 3 (6.8) | 2 (3.6) | 1 (1.8) | 1 (1.8) | 1 (1.8) | — | 5 (8.9) |
df_adverse_events
patient_id | trt | adverse_event | system_organ_class | grade |
---|---|---|---|---|
ID 1 | Drug B | Anaemia | Blood and lymphatic system disorders | 4 |
ID 1 | Drug B | Increased tendency to bruise | Blood and lymphatic system disorders | 5 |
ID 1 | Drug B | Increased tendency to bruise | Blood and lymphatic system disorders | 4 |
ID 1 | Drug B | Thrombocytopenia | Blood and lymphatic system disorders | 1 |
ID 1 | Drug B | Thrombocytopenia | Blood and lymphatic system disorders | 3 |
df_patient_characteristics
patient_id | trt |
---|---|
ID 1 | Drug B |
ID 2 | Drug B |
ID 3 | Drug B |
ID 4 | Drug B |
ID 5 | Drug B |
Introduction
About adverse events
First adverse event tables
Modified adverse event tables
Other convenience functions
Exporting options
Create summary tables with standard regulatory formatting.
Characteristic | Drug A, N = 441 | Drug B, N = 561 |
---|---|---|
Biological Marker | ||
N | 44 | 56 |
Mean (SD) | 5.47 (0.97) | 5.46 (1.04) |
Median (IQR) | 5.27 (4.98, 5.91) | 5.43 (4.67, 6.10) |
Range | 3.53, 8.42 | 3.66, 8.00 |
N missing | 0 | 0 |
Study Status | ||
Completed Study | 20 (45%) | 29 (52%) |
Adverse Event | 4 (9.1%) | 10 (18%) |
Progressive Disease | 4 (9.1%) | 4 (7.1%) |
Physician Decision | 5 (11%) | 3 (5.4%) |
Subject Withdrew | 4 (9.1%) | 6 (11%) |
Active | 7 (16%) | 4 (7.1%) |
1 n (%) |
df_patient_characteristics
patient_id | trt | marker | status |
---|---|---|---|
ID 1 | Drug B | 4.807148 | Adverse Event |
ID 2 | Drug B | 7.714544 | Completed Study |
ID 3 | Drug B | 6.449793 | Completed Study |
ID 4 | Drug B | 6.319944 | Subject Withdrew |
ID 5 | Drug B | 5.785283 | Physician Decision |
A fancy 💅 way to print grouped data.
Adverse Event | Grade | Drug Attribution | Patient ID |
---|---|---|---|
Blood and lymphatic system disorders | |||
Anaemia | 4 | Unrelated | ID 1 |
Increased tendency to bruise | 5 | Unrelated | ID 1 |
Increased tendency to bruise | 4 | Unlikely | ID 1 |
Thrombocytopenia | 3 | Definite | ID 1 |
Thrombocytopenia | 1 | Probably | ID 1 |
Gastrointestinal disorders | |||
Intestinal dilatation | 2 | Definite | ID 1 |
Intestinal dilatation | 1 | Definite | ID 1 |
Myochosis | 5 | Probably | ID 1 |
Myochosis | 3 | Unlikely | ID 1 |
Non-erosive reflux disease | 5 | Unrelated | ID 1 |
df_adverse_events
system_organ_class | adverse_event | grade | drug_attribution | patient_id |
---|---|---|---|---|
Blood and lymphatic system disorders | Anaemia | 4 | Unrelated | ID 1 |
Blood and lymphatic system disorders | Increased tendency to bruise | 5 | Unrelated | ID 1 |
Blood and lymphatic system disorders | Increased tendency to bruise | 4 | Unlikely | ID 1 |
Gastrointestinal disorders | Intestinal dilatation | 2 | Definite | ID 1 |
Gastrointestinal disorders | Intestinal dilatation | 1 | Definite | ID 1 |
Gastrointestinal disorders | Myochosis | 5 | Probably | ID 1 |
Gastrointestinal disorders | Myochosis | 3 | Unlikely | ID 1 |
Gastrointestinal disorders | Non-erosive reflux disease | 5 | Unrelated | ID 1 |
Blood and lymphatic system disorders | Thrombocytopenia | 3 | Definite | ID 1 |
Blood and lymphatic system disorders | Thrombocytopenia | 1 | Probably | ID 1 |
Remember this table?
Patient ID | System Organ Class | Adverse Event | Grade |
---|---|---|---|
Term 1 | |||
ID 1 | Blood and lymphatic system disorders | Anaemia | 4 |
Term 2 | |||
ID 1 | Blood and lymphatic system disorders | Increased tendency to bruise | 5 |
ID 1 | Blood and lymphatic system disorders | Increased tendency to bruise | 4 |
Term 3 | |||
ID 1 | Blood and lymphatic system disorders | Thrombocytopenia | 1 |
ID 1 | Blood and lymphatic system disorders | Thrombocytopenia | 3 |
patient_id | system_organ_class | adverse_event | grade | ae_label |
---|---|---|---|---|
ID 1 | Blood and lymphatic system disorders | Anaemia | 4 | Term 1 |
ID 1 | Blood and lymphatic system disorders | Increased tendency to bruise | 5 | Term 2 |
ID 1 | Blood and lymphatic system disorders | Increased tendency to bruise | 4 | Term 2 |
ID 1 | Blood and lymphatic system disorders | Thrombocytopenia | 1 | Term 3 |
ID 1 | Blood and lymphatic system disorders | Thrombocytopenia | 3 | Term 3 |
Introduction
About adverse events
First adverse event tables
Modified adverse event tables
Other convenience functions
Exporting options
Adverse Event | N = 100 | ||||
---|---|---|---|---|---|
Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | |
Blood and lymphatic system disorders | — | 1 (1.0) | — | 2 (2.0) | 7 (7.0) |
Anaemia | — | — | 2 (2.0) | 2 (2.0) | 3 (3.0) |
Increased tendency to bruise | — | — | — | 4 (4.0) | 2 (2.0) |
Iron deficiency anaemia | 1 (1.0) | 2 (2.0) | — | 2 (2.0) | 2 (2.0) |
Thrombocytopenia | — | 1 (1.0) | 3 (3.0) | 1 (1.0) | 4 (4.0) |
Gastrointestinal disorders | — | — | — | 4 (4.0) | 6 (6.0) |
Difficult digestion | 1 (1.0) | — | — | 3 (3.0) | 1 (1.0) |
Intestinal dilatation | 2 (2.0) | 1 (1.0) | — | — | 1 (1.0) |
Myochosis | — | 3 (3.0) | 1 (1.0) | 1 (1.0) | 3 (3.0) |
Non-erosive reflux disease | 4 (4.0) | — | — | 3 (3.0) | 3 (3.0) |
Pancreatic enzyme abnormality | 2 (2.0) | 1 (1.0) | 2 (2.0) | 2 (2.0) | 1 (1.0) |
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https://github.com/shannonpileggi/gtreg/issues
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