Cette vignette a pour but de faire le parallèle entre les macros SAS
de description des AE et les fonctions disponibles dans le package
grstat.
Elle reprend le document Word des macros SAS et n’existe que pour donner la correspondance entre les deux systèmes.
Pour apprendre comment utiliser grstat pour décrire les
AE, utilisez plutôt la vignette dédiée.
On commence par charger la base de données.
Ici j’utilise la fonction grstat_example() pour ne pas
dépendre de données réelles privées, mais en pratique on utiliserait
plutôt EDCimport::read_trialmaster("path/to/file.zip").
On s’intéresse à deux datasets : - ae qui contient les
données d’adverse events - enrolres qui contient tous les
patients et leur bras de traitement.
library(grstat)
library(flextable)
library(dplyr)
# tm = EDCimport::read_trialmaster("path/to/file.zip")
tm = grstat_example()
attach(tm)
head(ae)
#> # A tibble: 6 × 7
#> subjid aesoc aeterm aegr sae n_ae crfname
#> <int> <chr> <chr> <int> <fct> <int> <chr>
#> 1 1 Immune system disorders Immune sy… 4 No 3 ae
#> 2 1 Social circumstances Cultural … 1 No 3 ae
#> 3 1 Metabolism and nutrition disorders Nutrition… 1 No 3 ae
#> 4 2 Surgical and medical procedures Therapeut… 2 No 3 ae
#> 5 2 Surgical and medical procedures Therapeut… 2 No 3 ae
#> 6 2 Infections and infestations Fungal in… 2 No 3 ae
head(enrolres)
#> # A tibble: 6 × 4
#> subjid arm arm3 crfname
#> <int> <chr> <chr> <chr>
#> 1 1 Treatment Control enrolres
#> 2 2 Treatment Treatment A enrolres
#> 3 3 Control Control enrolres
#> 4 4 Control Treatment B enrolres
#> 5 5 Control Control enrolres
#> 6 6 Treatment Treatment B enrolresAE_grades
La macro AE_grades est implémentée dans la fonction
ae_table_grade(). Cette fonction retourne des objets de
classe crosstable, lesquels ont une méthode
as_flextable() qui les transforme en table HTML de classe
flextable.
Voir la description du package crosstable pour plus
d’informations: documentation.
Voir la description du package flextable pour la
liste des modificateurs (comme add_footer_lines()) : documentation.
AE_grades1 : Table des grades maximum par patient
ae_table_grade(df_ae=ae, df_enrol=enrolres, arm=NULL, variant="max") %>%
as_flextable(header_show_n=TRUE) %>%
add_footer_lines("Percentages reflect the proportion of patients whose maximum AE grade was as indicated.")label |
variable |
Treatment arm |
|---|---|---|
All patients (N=50) | ||
Patient maximum AE grade |
No declared AE |
1 (2%) |
Grade 1 |
4 (8%) |
|
Grade 2 |
11 (22%) |
|
Grade 3 |
15 (30%) |
|
Grade 4 |
17 (34%) |
|
Grade 5 |
2 (4%) |
|
Percentages reflect the proportion of patients whose maximum AE grade was as indicated. | ||
AE_grades2 : Table des grades maximum par patient
stratifié sur le bras
On pourrait retrouver exactement la sortie SAS en mettant
total=FALSE.
ae_table_grade(df_ae=ae, df_enrol=enrolres, arm="arm", variant="max") %>%
as_flextable(header_show_n=TRUE) %>%
add_footer_lines("Percentages reflect the proportion of patients presenting at most one AE of given grade")label |
variable |
Treatment arm |
Total |
|
|---|---|---|---|---|
Control (N=25) |
Treatment (N=25) |
|||
Patient maximum AE grade |
No declared AE |
0 (0%) |
1 (4%) |
1 (2%) |
Grade 1 |
2 (8%) |
2 (8%) |
4 (8%) |
|
Grade 2 |
4 (16%) |
7 (28%) |
11 (22%) |
|
Grade 3 |
8 (32%) |
7 (28%) |
15 (30%) |
|
Grade 4 |
9 (36%) |
8 (32%) |
17 (34%) |
|
Grade 5 |
2 (8%) |
0 (0%) |
2 (4%) |
|
Percentages reflect the proportion of patients presenting at most one AE of given grade | ||||
AE_grades3 : Table de tous les grades pour chaque
patient
ae_table_grade(df_ae=ae, df_enrol=enrolres, arm=NULL, variant="eq") %>%
as_flextable(header_show_n=TRUE) %>%
add_footer_lines("Percentages reflect the proportion of patients presenting at least one AE of given grade")label |
variable |
Treatment arm |
|---|---|---|
All patients (N=50) | ||
Patient had at least one AE of grade |
No declared AE |
1 (2%) |
Grade 1 |
35 (70%) |
|
Grade 2 |
29 (58%) |
|
Grade 3 |
22 (44%) |
|
Grade 4 |
17 (34%) |
|
Grade 5 |
2 (4%) |
|
Percentages reflect the proportion of patients presenting at least one AE of given grade | ||
AE_grades3bis : Table de tous les grades pour chaque
patient, stratifié sur le bras
On pourrait retrouver exactement la sortie SAS en mettant
total=FALSE.
ae_table_grade(df_ae=ae, df_enrol=enrolres, arm="arm", variant="eq") %>%
as_flextable(header_show_n=TRUE) %>%
add_footer_lines("Percentages reflect the proportion of patients presenting at least one AE of given grade")label |
variable |
Treatment arm |
Total |
|
|---|---|---|---|---|
Control (N=25) |
Treatment (N=25) |
|||
Patient had at least one AE of grade |
No declared AE |
0 (0%) |
1 (4%) |
1 (2%) |
Grade 1 |
18 (72%) |
17 (68%) |
35 (70%) |
|
Grade 2 |
16 (64%) |
13 (52%) |
29 (58%) |
|
Grade 3 |
13 (52%) |
9 (36%) |
22 (44%) |
|
Grade 4 |
9 (36%) |
8 (32%) |
17 (34%) |
|
Grade 5 |
2 (8%) |
0 (0%) |
2 (4%) |
|
Percentages reflect the proportion of patients presenting at least one AE of given grade | ||||
AE_grades4 : Table des grades maximum par patient,
filtrée sur les SAE
Il suffit de filtrer la table ae en amont et d’indiquer
que le label doit être “SAE”.
ae %>%
filter(sae=="Yes") %>%
ae_table_grade(df_enrol=enrolres, arm=NULL, variant="max", ae_label="SAE") %>%
as_flextable(header_show_n=TRUE) %>%
add_footer_lines("Percentages reflect the proportion of patients whose maximum SAE grade was as indicated.")label |
variable |
Treatment arm |
|---|---|---|
All patients (N=50) | ||
Patient maximum SAE grade |
No declared SAE |
37 (74%) |
Grade 1 |
1 (2%) |
|
Grade 2 |
1 (2%) |
|
Grade 3 |
7 (14%) |
|
Grade 4 |
2 (4%) |
|
Grade 5 |
2 (4%) |
|
Percentages reflect the proportion of patients whose maximum SAE grade was as indicated. | ||
AE_SOC
La macro AE_SOC est implémentée dans la fonction
ae_table_soc(). Cette fonction retourne des objets de
classe ae_table_soc. Ils ont également une méthode
as_flextable qui les transforme en table HTML de classe
flextable, mais différente de celle de
crosstable.
Voir ?as_flextable.ae_table_soc pour plus
d’informations: lien.
Voir la description du package flextable pour la
liste des modificateurs (comme add_footer_lines()) : documentation.
Astuce: Pour les sorties sur officer,
comme ces tables sont très larges, pensez bien à basculer en format
paysage en utilisant
officer::body_end_section_continuous(), puis
officer::body_end_section_landscape() pour revenir au
format portrait.
AE_SOC1 : Table des grades par soc
On peut ajouter total=FALSE pour retirer la colonne
“Tot”.
ae_table_soc(df_ae=ae, df_enrol=enrolres, arm=NULL, term=NULL,
sort_by_count=FALSE) %>%
as_flextable() %>%
add_footer_lines("In the header, N represents the number of patients.") %>%
add_footer_lines("Percentages reflect the proportion of patients whose maximum AE grade was as indicated.")All patients (N=50) |
|||||||
|---|---|---|---|---|---|---|---|
CTCAE SOC |
G1 |
G2 |
G3 |
G4 |
G5 |
NA |
Tot |
Blood and lymphatic system disorders |
2 (4%) |
2 (4%) |
1 (2%) |
5 (10%) |
|||
Cardiac disorders |
3 (6%) |
2 (4%) |
1 (2%) |
6 (12%) |
|||
Congenital, familial and genetic disorders |
3 (6%) |
3 (6%) |
1 (2%) |
7 (14%) |
|||
Ear and labyrinth disorders |
1 (2%) |
1 (2%) |
|||||
Endocrine disorders |
1 (2%) |
3 (6%) |
2 (4%) |
6 (12%) |
|||
Eye disorders |
2 (4%) |
1 (2%) |
3 (6%) |
||||
Gastrointestinal disorders |
1 (2%) |
1 (2%) |
1 (2%) |
3 (6%) |
6 (12%) |
||
General disorders and administration site conditions |
4 (8%) |
1 (2%) |
2 (4%) |
1 (2%) |
8 (16%) |
||
Hepatobiliary disorders |
2 (4%) |
1 (2%) |
3 (6%) |
||||
Immune system disorders |
3 (6%) |
2 (4%) |
3 (6%) |
2 (4%) |
10 (20%) |
||
Infections and infestations |
2 (4%) |
4 (8%) |
2 (4%) |
8 (16%) |
|||
Injury, poisoning and procedural complications |
1 (2%) |
2 (4%) |
3 (6%) |
||||
Investigations |
3 (6%) |
4 (8%) |
2 (4%) |
2 (4%) |
1 (2%) |
12 (24%) |
|
Metabolism and nutrition disorders |
2 (4%) |
1 (2%) |
1 (2%) |
1 (2%) |
5 (10%) |
||
Musculoskeletal and connective tissue disorders |
2 (4%) |
2 (4%) |
4 (8%) |
||||
Neoplasms benign, malignant, and unspecified |
3 (6%) |
2 (4%) |
5 (10%) |
||||
Nervous system disorders |
1 (2%) |
1 (2%) |
1 (2%) |
3 (6%) |
|||
Pregnancy, puerperium and perinatal conditions |
3 (6%) |
3 (6%) |
1 (2%) |
7 (14%) |
|||
Psychiatric disorders |
2 (4%) |
5 (10%) |
7 (14%) |
||||
Renal and urinary disorders |
2 (4%) |
1 (2%) |
3 (6%) |
||||
Reproductive system and breast disorders |
5 (10%) |
1 (2%) |
6 (12%) |
||||
Respiratory, thoracic and mediastinal disorders |
1 (2%) |
2 (4%) |
1 (2%) |
1 (2%) |
5 (10%) |
||
Skin and subcutaneous tissue disorders |
2 (4%) |
1 (2%) |
3 (6%) |
||||
Social circumstances |
4 (8%) |
1 (2%) |
2 (4%) |
7 (14%) |
|||
Surgical and medical procedures |
2 (4%) |
3 (6%) |
5 (10%) |
||||
Vascular disorders |
1 (2%) |
1 (2%) |
2 (4%) |
||||
No Declared AE |
1 (2%) |
1 (2%) |
|||||
In the header, N represents the number of patients. | |||||||
Percentages reflect the proportion of patients whose maximum AE grade was as indicated. | |||||||
AE_SOC2 : Table des grades par soc et termes
ae_table_soc(df_ae=ae, df_enrol=enrolres, arm=NULL, term="aeterm",
sort_by_count=FALSE) %>%
as_flextable() %>%
add_footer_lines("In the header, N represents the number of patients.") %>%
add_footer_lines("Percentages reflect the proportion of patients whose maximum AE grade was as indicated.")All patients (N=50) |
||||||||
|---|---|---|---|---|---|---|---|---|
CTCAE SOC |
CTCAE v4.0 Term |
G1 |
G2 |
G3 |
G4 |
G5 |
NA |
Tot |
Blood and lymphatic system disorders |
Bone marrow disorders |
1 (2%) |
1 (2%) |
|||||
Blood and lymphatic system disorders |
Coagulation and bleeding analyses |
2 (4%) |
1 (2%) |
3 (6%) |
||||
Blood and lymphatic system disorders |
Red blood cell disorders |
1 (2%) |
1 (2%) |
|||||
Cardiac disorders |
Coronary artery disorders |
2 (4%) |
1 (2%) |
3 (6%) |
||||
Cardiac disorders |
Heart failures |
3 (6%) |
3 (6%) |
|||||
Congenital, familial and genetic disorders |
Chromosomal abnormalities |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Congenital, familial and genetic disorders |
Congenital nervous system disorders |
1 (2%) |
1 (2%) |
|||||
Congenital, familial and genetic disorders |
Familial hematologic disorders |
2 (4%) |
1 (2%) |
3 (6%) |
||||
Congenital, familial and genetic disorders |
Hereditary connective tissue disorders |
1 (2%) |
1 (2%) |
|||||
Ear and labyrinth disorders |
Hearing disorders |
1 (2%) |
1 (2%) |
|||||
Endocrine disorders |
Adrenal gland disorders |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Endocrine disorders |
Parathyroid gland disorders |
2 (4%) |
2 (4%) |
4 (8%) |
||||
Eye disorders |
Corneal disorders |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Eye disorders |
Eyelid disorders |
1 (2%) |
1 (2%) |
|||||
Eye disorders |
Vision disorders |
1 (2%) |
1 (2%) |
|||||
Gastrointestinal disorders |
Esophageal disorders |
1 (2%) |
2 (4%) |
3 (6%) |
||||
Gastrointestinal disorders |
Gastrointestinal motility and defecation conditions |
1 (2%) |
1 (2%) |
|||||
Gastrointestinal disorders |
Intestinal disorders |
1 (2%) |
1 (2%) |
1 (2%) |
3 (6%) |
|||
General disorders and administration site conditions |
Device issues |
1 (2%) |
1 (2%) |
|||||
General disorders and administration site conditions |
General physical health deterioration |
1 (2%) |
2 (4%) |
3 (6%) |
||||
General disorders and administration site conditions |
Injection site reactions |
2 (4%) |
2 (4%) |
|||||
General disorders and administration site conditions |
Pain and discomfort |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Hepatobiliary disorders |
Bile duct disorders |
1 (2%) |
1 (2%) |
|||||
Hepatobiliary disorders |
Gallbladder disorders |
1 (2%) |
1 (2%) |
|||||
Hepatobiliary disorders |
Hepatic failure |
1 (2%) |
1 (2%) |
|||||
Immune system disorders |
Alloimmune responses |
1 (2%) |
1 (2%) |
|||||
Immune system disorders |
Autoimmune disorders |
1 (2%) |
1 (2%) |
|||||
Immune system disorders |
Hypersensitivity conditions |
1 (2%) |
1 (2%) |
1 (2%) |
3 (6%) |
|||
Immune system disorders |
Immune system analysis disorders |
1 (2%) |
1 (2%) |
|||||
Immune system disorders |
Immune-mediated adverse events |
1 (2%) |
2 (4%) |
3 (6%) |
||||
Immune system disorders |
Inflammatory responses |
1 (2%) |
1 (2%) |
|||||
Infections and infestations |
Bacterial infectious disorders |
1 (2%) |
1 (2%) |
|||||
Infections and infestations |
Fungal infectious disorders |
1 (2%) |
1 (2%) |
1 (2%) |
3 (6%) |
|||
Infections and infestations |
Parasitic infectious disorders |
1 (2%) |
1 (2%) |
|||||
Infections and infestations |
Viral infectious disorders |
2 (4%) |
1 (2%) |
3 (6%) |
||||
Injury, poisoning and procedural complications |
Procedural complications |
1 (2%) |
1 (2%) |
|||||
Injury, poisoning and procedural complications |
Radiation-related toxicities |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Investigations |
Blood analyses |
2 (4%) |
1 (2%) |
2 (4%) |
5 (10%) |
|||
Investigations |
Cardiovascular assessments |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Investigations |
Imaging studies |
2 (4%) |
1 (2%) |
3 (6%) |
||||
Investigations |
Liver function analyses |
1 (2%) |
1 (2%) |
1 (2%) |
3 (6%) |
|||
Metabolism and nutrition disorders |
Lipid metabolism disorders |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Metabolism and nutrition disorders |
Nutritional disorders |
1 (2%) |
1 (2%) |
|||||
Metabolism and nutrition disorders |
Vitamin deficiencies |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Musculoskeletal and connective tissue disorders |
Arthritis and joint disorders |
1 (2%) |
1 (2%) |
|||||
Musculoskeletal and connective tissue disorders |
Bone disorders |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Musculoskeletal and connective tissue disorders |
Muscle disorders |
1 (2%) |
1 (2%) |
|||||
Neoplasms benign, malignant, and unspecified |
Benign neoplasms |
1 (2%) |
1 (2%) |
|||||
Neoplasms benign, malignant, and unspecified |
Malignant neoplasms |
1 (2%) |
1 (2%) |
|||||
Neoplasms benign, malignant, and unspecified |
Neoplasms unspecified |
1 (2%) |
1 (2%) |
|||||
Neoplasms benign, malignant, and unspecified |
Tumor progression |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Nervous system disorders |
Seizure disorders |
1 (2%) |
1 (2%) |
1 (2%) |
3 (6%) |
|||
Pregnancy, puerperium and perinatal conditions |
Breastfeeding issues |
1 (2%) |
1 (2%) |
|||||
Pregnancy, puerperium and perinatal conditions |
Fetal complications |
1 (2%) |
2 (4%) |
3 (6%) |
||||
Pregnancy, puerperium and perinatal conditions |
Labor and delivery complications |
1 (2%) |
1 (2%) |
|||||
Pregnancy, puerperium and perinatal conditions |
Pregnancy complications |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Psychiatric disorders |
Anxiety disorders |
1 (2%) |
4 (8%) |
5 (10%) |
||||
Psychiatric disorders |
Mood disorders |
1 (2%) |
1 (2%) |
|||||
Psychiatric disorders |
Substance-related disorders |
1 (2%) |
1 (2%) |
|||||
Renal and urinary disorders |
Bladder disorders |
1 (2%) |
1 (2%) |
|||||
Renal and urinary disorders |
Urethral disorders |
1 (2%) |
1 (2%) |
|||||
Renal and urinary disorders |
Urinary tract disorders |
1 (2%) |
1 (2%) |
|||||
Reproductive system and breast disorders |
Breast disorders |
1 (2%) |
1 (2%) |
|||||
Reproductive system and breast disorders |
Female reproductive disorders |
2 (4%) |
2 (4%) |
|||||
Reproductive system and breast disorders |
Male reproductive disorders |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Reproductive system and breast disorders |
Menstrual disorders |
1 (2%) |
1 (2%) |
|||||
Respiratory, thoracic and mediastinal disorders |
Lung function disorders |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Respiratory, thoracic and mediastinal disorders |
Pleural disorders |
1 (2%) |
1 (2%) |
1 (2%) |
3 (6%) |
|||
Respiratory, thoracic and mediastinal disorders |
Respiratory infections |
1 (2%) |
1 (2%) |
|||||
Skin and subcutaneous tissue disorders |
Skin infections |
1 (2%) |
1 (2%) |
|||||
Skin and subcutaneous tissue disorders |
Skin pigmentation disorders |
2 (4%) |
2 (4%) |
|||||
Social circumstances |
Cultural issues |
2 (4%) |
1 (2%) |
3 (6%) |
||||
Social circumstances |
Economic conditions affecting care |
1 (2%) |
1 (2%) |
|||||
Social circumstances |
Family support issues |
1 (2%) |
1 (2%) |
|||||
Social circumstances |
Social and environmental issues |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Surgical and medical procedures |
Device implantation procedures |
1 (2%) |
1 (2%) |
|||||
Surgical and medical procedures |
Diagnostic procedures |
1 (2%) |
1 (2%) |
|||||
Surgical and medical procedures |
Surgical complications |
1 (2%) |
1 (2%) |
|||||
Surgical and medical procedures |
Therapeutic procedures |
3 (6%) |
3 (6%) |
|||||
Vascular disorders |
Hypotension-related conditions |
1 (2%) |
1 (2%) |
|||||
Vascular disorders |
Vascular hemorrhagic disorders |
1 (2%) |
1 (2%) |
|||||
No Declared AE |
1 (2%) |
1 (2%) |
||||||
In the header, N represents the number of patients. | ||||||||
Percentages reflect the proportion of patients whose maximum AE grade was as indicated. | ||||||||
AE_SOC3 : Table des grades par termes uniquement,
filtrée sur les SAE
Il suffit de filtrer la table AE en amont.
ae %>%
filter(sae=="Yes") %>%
ae_table_soc(df_enrol=enrolres, term=NULL, arm=NULL, sort_by_count=FALSE) %>%
as_flextable() %>%
add_footer_lines(c("In the header, N represents the number of patients.",
"Percentages reflect the proportion of patients whose maximum SAE grade was as indicated."))All patients (N=50) |
|||||||
|---|---|---|---|---|---|---|---|
CTCAE SOC |
G1 |
G2 |
G3 |
G4 |
G5 |
NA |
Tot |
Congenital, familial and genetic disorders |
1 (2%) |
1 (2%) |
|||||
Endocrine disorders |
1 (2%) |
1 (2%) |
|||||
General disorders and administration site conditions |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Immune system disorders |
1 (2%) |
1 (2%) |
2 (4%) |
||||
Infections and infestations |
1 (2%) |
1 (2%) |
|||||
Investigations |
1 (2%) |
1 (2%) |
|||||
Musculoskeletal and connective tissue disorders |
1 (2%) |
1 (2%) |
|||||
Pregnancy, puerperium and perinatal conditions |
2 (4%) |
2 (4%) |
|||||
Reproductive system and breast disorders |
1 (2%) |
1 (2%) |
|||||
Respiratory, thoracic and mediastinal disorders |
1 (2%) |
1 (2%) |
|||||
Social circumstances |
1 (2%) |
1 (2%) |
|||||
Vascular disorders |
1 (2%) |
1 (2%) |
|||||
No Declared AE |
37 (74%) |
37 (74%) |
|||||
In the header, N represents the number of patients. | |||||||
Percentages reflect the proportion of patients whose maximum SAE grade was as indicated. | |||||||
AE_SOC4/5 : Table des grades stratifiée sur le bras
(sans colonne total)
On peut ajouter total=FALSE pour retirer la colonne
“Tot” et obtenir la sortie AE_SOC5.
ae_table_soc(df_ae=ae, df_enrol=enrolres, term=NULL, arm="arm", sort_by_count=FALSE) %>%
as_flextable() %>%
add_footer_lines("In the header, N represents the number of patients.") %>%
add_footer_lines("Percentages reflect the proportion of patients whose maximum AE grade was as indicated.")Control (N=25) |
Treatment (N=25) |
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CTCAE SOC |
G1 |
G2 |
G3 |
G4 |
G5 |
NA |
Tot |
G1 |
G2 |
G3 |
G4 |
G5 |
NA |
Tot |
Blood and lymphatic system disorders |
2 (8%) |
2 (8%) |
1 (4%) |
5 (20%) |
||||||||||
Cardiac disorders |
2 (8%) |
2 (8%) |
1 (4%) |
5 (20%) |
1 (4%) |
1 (4%) |
||||||||
Congenital, familial and genetic disorders |
2 (8%) |
2 (8%) |
1 (4%) |
5 (20%) |
1 (4%) |
1 (4%) |
2 (8%) |
|||||||
Ear and labyrinth disorders |
1 (4%) |
1 (4%) |
||||||||||||
Endocrine disorders |
1 (4%) |
2 (8%) |
3 (12%) |
1 (4%) |
2 (8%) |
3 (12%) |
||||||||
Eye disorders |
1 (4%) |
1 (4%) |
2 (8%) |
2 (8%) |
||||||||||
Gastrointestinal disorders |
1 (4%) |
1 (4%) |
1 (4%) |
3 (12%) |
6 (24%) |
|||||||||
General disorders and administration site conditions |
2 (8%) |
1 (4%) |
3 (12%) |
2 (8%) |
1 (4%) |
2 (8%) |
5 (20%) |
|||||||
Hepatobiliary disorders |
1 (4%) |
1 (4%) |
2 (8%) |
2 (8%) |
||||||||||
Immune system disorders |
2 (8%) |
2 (8%) |
4 (16%) |
1 (4%) |
2 (8%) |
1 (4%) |
2 (8%) |
6 (24%) |
||||||
Infections and infestations |
2 (8%) |
2 (8%) |
2 (8%) |
6 (24%) |
2 (8%) |
2 (8%) |
||||||||
Injury, poisoning and procedural complications |
1 (4%) |
1 (4%) |
2 (8%) |
1 (4%) |
1 (4%) |
|||||||||
Investigations |
2 (8%) |
3 (12%) |
1 (4%) |
2 (8%) |
1 (4%) |
9 (36%) |
1 (4%) |
1 (4%) |
1 (4%) |
3 (12%) |
||||
Metabolism and nutrition disorders |
1 (4%) |
1 (4%) |
2 (8%) |
1 (4%) |
1 (4%) |
1 (4%) |
3 (12%) |
|||||||
Musculoskeletal and connective tissue disorders |
2 (8%) |
2 (8%) |
2 (8%) |
2 (8%) |
||||||||||
Neoplasms benign, malignant, and unspecified |
3 (12%) |
2 (8%) |
5 (20%) |
|||||||||||
Nervous system disorders |
1 (4%) |
1 (4%) |
1 (4%) |
1 (4%) |
2 (8%) |
|||||||||
Pregnancy, puerperium and perinatal conditions |
1 (4%) |
3 (12%) |
1 (4%) |
5 (20%) |
2 (8%) |
2 (8%) |
||||||||
Psychiatric disorders |
1 (4%) |
2 (8%) |
3 (12%) |
1 (4%) |
3 (12%) |
4 (16%) |
||||||||
Renal and urinary disorders |
1 (4%) |
1 (4%) |
1 (4%) |
1 (4%) |
2 (8%) |
|||||||||
Reproductive system and breast disorders |
4 (16%) |
1 (4%) |
5 (20%) |
1 (4%) |
1 (4%) |
|||||||||
Respiratory, thoracic and mediastinal disorders |
1 (4%) |
1 (4%) |
2 (8%) |
1 (4%) |
1 (4%) |
1 (4%) |
3 (12%) |
|||||||
Skin and subcutaneous tissue disorders |
2 (8%) |
1 (4%) |
3 (12%) |
|||||||||||
Social circumstances |
2 (8%) |
1 (4%) |
1 (4%) |
4 (16%) |
2 (8%) |
1 (4%) |
3 (12%) |
|||||||
Surgical and medical procedures |
1 (4%) |
1 (4%) |
2 (8%) |
2 (8%) |
4 (16%) |
|||||||||
Vascular disorders |
1 (4%) |
1 (4%) |
2 (8%) |
|||||||||||
No Declared AE |
1 (4%) |
1 (4%) |
||||||||||||
In the header, N represents the number of patients. | ||||||||||||||
Percentages reflect the proportion of patients whose maximum AE grade was as indicated. | ||||||||||||||
AE_SOC6 : Table des soc et termes tous grades confondus
stratifiée sur le bras
ae_table_soc(df_ae=ae, df_enrol=enrolres, arm="arm", term="aeterm",
sort_by_count=FALSE) %>%
as_flextable() %>%
add_footer_lines("In the header, N represents the number of patients.") %>%
add_footer_lines("Percentages reflect the proportion of patients whose maximum AE grade was as indicated.")Control (N=25) |
Treatment (N=25) |
||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CTCAE SOC |
CTCAE v4.0 Term |
G1 |
G2 |
G3 |
G4 |
G5 |
NA |
Tot |
G1 |
G2 |
G3 |
G4 |
G5 |
NA |
Tot |
Blood and lymphatic system disorders |
Bone marrow disorders |
1 (4%) |
1 (4%) |
||||||||||||
Blood and lymphatic system disorders |
Coagulation and bleeding analyses |
2 (8%) |
1 (4%) |
3 (12%) |
|||||||||||
Blood and lymphatic system disorders |
Red blood cell disorders |
1 (4%) |
1 (4%) |
||||||||||||
Cardiac disorders |
Coronary artery disorders |
2 (8%) |
1 (4%) |
3 (12%) |
|||||||||||
Cardiac disorders |
Heart failures |
2 (8%) |
2 (8%) |
1 (4%) |
1 (4%) |
||||||||||
Congenital, familial and genetic disorders |
Chromosomal abnormalities |
1 (4%) |
1 (4%) |
2 (8%) |
|||||||||||
Congenital, familial and genetic disorders |
Congenital nervous system disorders |
1 (4%) |
1 (4%) |
||||||||||||
Congenital, familial and genetic disorders |
Familial hematologic disorders |
2 (8%) |
1 (4%) |
3 (12%) |
|||||||||||
Congenital, familial and genetic disorders |
Hereditary connective tissue disorders |
1 (4%) |
1 (4%) |
||||||||||||
Ear and labyrinth disorders |
Hearing disorders |
1 (4%) |
1 (4%) |
||||||||||||
Endocrine disorders |
Adrenal gland disorders |
1 (4%) |
1 (4%) |
2 (8%) |
|||||||||||
Endocrine disorders |
Parathyroid gland disorders |
1 (4%) |
1 (4%) |
1 (4%) |
2 (8%) |
3 (12%) |
|||||||||
Eye disorders |
Corneal disorders |
1 (4%) |
1 (4%) |
1 (4%) |
1 (4%) |
||||||||||
Eye disorders |
Eyelid disorders |
1 (4%) |
1 (4%) |
||||||||||||
Eye disorders |
Vision disorders |
1 (4%) |
1 (4%) |
||||||||||||
Gastrointestinal disorders |
Esophageal disorders |
1 (4%) |
2 (8%) |
3 (12%) |
|||||||||||
Gastrointestinal disorders |
Gastrointestinal motility and defecation conditions |
1 (4%) |
1 (4%) |
||||||||||||
Gastrointestinal disorders |
Intestinal disorders |
1 (4%) |
1 (4%) |
1 (4%) |
3 (12%) |
||||||||||
General disorders and administration site conditions |
Device issues |
1 (4%) |
1 (4%) |
||||||||||||
General disorders and administration site conditions |
General physical health deterioration |
1 (4%) |
1 (4%) |
2 (8%) |
2 (8%) |
||||||||||
General disorders and administration site conditions |
Injection site reactions |
1 (4%) |
1 (4%) |
1 (4%) |
1 (4%) |
||||||||||
General disorders and administration site conditions |
Pain and discomfort |
1 (4%) |
1 (4%) |
2 (8%) |
|||||||||||
Hepatobiliary disorders |
Bile duct disorders |
1 (4%) |
1 (4%) |
||||||||||||
Hepatobiliary disorders |
Gallbladder disorders |
1 (4%) |
1 (4%) |
||||||||||||
Hepatobiliary disorders |
Hepatic failure |
1 (4%) |
1 (4%) |
||||||||||||
Immune system disorders |
Alloimmune responses |
1 (4%) |
1 (4%) |
||||||||||||
Immune system disorders |
Autoimmune disorders |
1 (4%) |
1 (4%) |
||||||||||||
Immune system disorders |
Hypersensitivity conditions |
1 (4%) |
1 (4%) |
1 (4%) |
1 (4%) |
2 (8%) |
|||||||||
Immune system disorders |
Immune system analysis disorders |
1 (4%) |
1 (4%) |
||||||||||||
Immune system disorders |
Immune-mediated adverse events |
1 (4%) |
1 (4%) |
1 (4%) |
1 (4%) |
2 (8%) |
|||||||||
Immune system disorders |
Inflammatory responses |
1 (4%) |
1 (4%) |
||||||||||||
Infections and infestations |
Bacterial infectious disorders |
1 (4%) |
1 (4%) |
||||||||||||
Infections and infestations |
Fungal infectious disorders |
1 (4%) |
1 (4%) |
2 (8%) |
1 (4%) |
1 (4%) |
|||||||||
Infections and infestations |
Parasitic infectious disorders |
1 (4%) |
1 (4%) |
||||||||||||
Infections and infestations |
Viral infectious disorders |
1 (4%) |
1 (4%) |
2 (8%) |
1 (4%) |
1 (4%) |
|||||||||
Injury, poisoning and procedural complications |
Procedural complications |
1 (4%) |
1 (4%) |
||||||||||||
Injury, poisoning and procedural complications |
Radiation-related toxicities |
1 (4%) |
1 (4%) |
2 (8%) |
|||||||||||
Investigations |
Blood analyses |
1 (4%) |
1 (4%) |
2 (8%) |
1 (4%) |
1 (4%) |
1 (4%) |
3 (12%) |
|||||||
Investigations |
Cardiovascular assessments |
1 (4%) |
1 (4%) |
2 (8%) |
|||||||||||
Investigations |
Imaging studies |
2 (8%) |
1 (4%) |
3 (12%) |
|||||||||||
Investigations |
Liver function analyses |
1 (4%) |
1 (4%) |
1 (4%) |
3 (12%) |
||||||||||
Metabolism and nutrition disorders |
Lipid metabolism disorders |
1 (4%) |
1 (4%) |
1 (4%) |
1 (4%) |
||||||||||
Metabolism and nutrition disorders |
Nutritional disorders |
1 (4%) |
1 (4%) |
||||||||||||
Metabolism and nutrition disorders |
Vitamin deficiencies |
1 (4%) |
1 (4%) |
1 (4%) |
1 (4%) |
||||||||||
Musculoskeletal and connective tissue disorders |
Arthritis and joint disorders |
1 (4%) |
1 (4%) |
||||||||||||
Musculoskeletal and connective tissue disorders |
Bone disorders |
1 (4%) |
1 (4%) |
1 (4%) |
1 (4%) |
||||||||||
Musculoskeletal and connective tissue disorders |
Muscle disorders |
1 (4%) |
1 (4%) |
||||||||||||
Neoplasms benign, malignant, and unspecified |
Benign neoplasms |
1 (4%) |
1 (4%) |
||||||||||||
Neoplasms benign, malignant, and unspecified |
Malignant neoplasms |
1 (4%) |
1 (4%) |
||||||||||||
Neoplasms benign, malignant, and unspecified |
Neoplasms unspecified |
1 (4%) |
1 (4%) |
||||||||||||
Neoplasms benign, malignant, and unspecified |
Tumor progression |
1 (4%) |
1 (4%) |
2 (8%) |
|||||||||||
Nervous system disorders |
Seizure disorders |
1 (4%) |
1 (4%) |
1 (4%) |
1 (4%) |
2 (8%) |
|||||||||
Pregnancy, puerperium and perinatal conditions |
Breastfeeding issues |
1 (4%) |
1 (4%) |
||||||||||||
Pregnancy, puerperium and perinatal conditions |
Fetal complications |
1 (4%) |
2 (8%) |
3 (12%) |
|||||||||||
Pregnancy, puerperium and perinatal conditions |
Labor and delivery complications |
1 (4%) |
1 (4%) |
||||||||||||
Pregnancy, puerperium and perinatal conditions |
Pregnancy complications |
1 (4%) |
1 (4%) |
1 (4%) |
1 (4%) |
||||||||||
Psychiatric disorders |
Anxiety disorders |
1 (4%) |
1 (4%) |
2 (8%) |
3 (12%) |
3 (12%) |
|||||||||
Psychiatric disorders |
Mood disorders |
1 (4%) |
1 (4%) |
||||||||||||
Psychiatric disorders |
Substance-related disorders |
1 (4%) |
1 (4%) |
||||||||||||
Renal and urinary disorders |
Bladder disorders |
1 (4%) |
1 (4%) |
||||||||||||
Renal and urinary disorders |
Urethral disorders |
1 (4%) |
1 (4%) |
||||||||||||
Renal and urinary disorders |
Urinary tract disorders |
1 (4%) |
1 (4%) |
||||||||||||
Reproductive system and breast disorders |
Breast disorders |
1 (4%) |
1 (4%) |
||||||||||||
Reproductive system and breast disorders |
Female reproductive disorders |
1 (4%) |
1 (4%) |
1 (4%) |
1 (4%) |
||||||||||
Reproductive system and breast disorders |
Male reproductive disorders |
1 (4%) |
1 (4%) |
2 (8%) |
|||||||||||
Reproductive system and breast disorders |
Menstrual disorders |
1 (4%) |
1 (4%) |
||||||||||||
Respiratory, thoracic and mediastinal disorders |
Lung function disorders |
1 (4%) |
1 (4%) |
1 (4%) |
1 (4%) |
||||||||||
Respiratory, thoracic and mediastinal disorders |
Pleural disorders |
1 (4%) |
1 (4%) |
1 (4%) |
1 (4%) |
2 (8%) |
|||||||||
Respiratory, thoracic and mediastinal disorders |
Respiratory infections |
1 (4%) |
1 (4%) |
||||||||||||
Skin and subcutaneous tissue disorders |
Skin infections |
1 (4%) |
1 (4%) |
||||||||||||
Skin and subcutaneous tissue disorders |
Skin pigmentation disorders |
2 (8%) |
2 (8%) |
||||||||||||
Social circumstances |
Cultural issues |
1 (4%) |
1 (4%) |
2 (8%) |
2 (8%) |
||||||||||
Social circumstances |
Economic conditions affecting care |
1 (4%) |
1 (4%) |
||||||||||||
Social circumstances |
Family support issues |
1 (4%) |
1 (4%) |
||||||||||||
Social circumstances |
Social and environmental issues |
1 (4%) |
1 (4%) |
1 (4%) |
1 (4%) |
||||||||||
Surgical and medical procedures |
Device implantation procedures |
1 (4%) |
1 (4%) |
||||||||||||
Surgical and medical procedures |
Diagnostic procedures |
1 (4%) |
1 (4%) |
||||||||||||
Surgical and medical procedures |
Surgical complications |
1 (4%) |
1 (4%) |
||||||||||||
Surgical and medical procedures |
Therapeutic procedures |
1 (4%) |
1 (4%) |
2 (8%) |
2 (8%) |
||||||||||
Vascular disorders |
Hypotension-related conditions |
1 (4%) |
1 (4%) |
||||||||||||
Vascular disorders |
Vascular hemorrhagic disorders |
1 (4%) |
1 (4%) |
||||||||||||
No Declared AE |
1 (4%) |
1 (4%) |
|||||||||||||
In the header, N represents the number of patients. | |||||||||||||||
Percentages reflect the proportion of patients whose maximum AE grade was as indicated. | |||||||||||||||