Summary tables for AE by SOC

The function ae_table_soc() creates a summary table of AE grades for each patient according to term and SOC CTCAE. The resulting dataframe can be piped to as_flextable() to get a nicely formatted flextable.

Usage

ae_table_soc(
  df_ae,
  ...,
  df_enrol,
  variant = c("max", "sup", "eq"),
  arm = NULL,
  term = NULL,
  sort_by_count = TRUE,
  total = TRUE,
  showNA = TRUE,
  digits = 0,
  warn_miss = FALSE,
  grade = "AEGR",
  soc = "AESOC",
  subjid = "SUBJID"
)

# S3 method for class 'ae_table_soc'
as_flextable(
  x,
  ...,
  arm_colors = c("#f2dcdb", "#dbe5f1", "#ebf1dd", "#e5e0ec"),
  padding_v = NULL
)

Arguments

df_ae: adverse event dataset, one row per AE, containing subjid, soc, and grade.
...: unused
df_enrol: enrollment dataset, one row per patient, containing subjid (and arm if needed). All patients should be in this dataset.
variant: one or several of c("max", "sup", "eq"). max computes the maximum AE grade per patient, sup computes the number of patients having experienced at least one AE of grade higher or equal to X, and eq computes the number of patients having experienced at least one AE of grade equal to X.
arm: name of the treatment column in df_enrol. Case-insensitive. Can be set to NULL.
term: name of the the CTCAE term column in df_ae. Case-insensitive. Can be set to NULL.
sort_by_count: should the table be sorted by the number of AE or by SOC alphabetically.
total: whether to add a total column for each arm.
showNA: whether to display missing grades.
digits: significant digits for percentages.
warn_miss: whether to warn for missing values.
grade: name of the AE grade column in df_ae. Case-insensitive.
soc: name of the SOC column in df_ae. Case-insensitive. Grade will be considered 0 if missing (e.g. if patient if absent from df_ae).
subjid: name of the patient ID in both df_ae and df_enrol. Case-insensitive.
x: a dataframe, resulting of ae_table_soc()
arm_colors: colors for the arm groups
padding_v: a numeric of lenght up to 2, giving the vertical padding of body (1) and header (2)

Value

a dataframe (ae_table_soc()) or a flextable (as_flextable()).

a formatted flextable

Examples

tm = grstat_example()
attach(tm, warn.conflicts=FALSE)

ae_table_soc(df_ae=ae, df_enrol=enrolres)
#> # A tibble: 27 × 8
#>    soc           all_patients_G1 all_patients_G2 all_patients_G3 all_patients_G4
#>    <fct>         <glue>          <glue>          <glue>          <glue>         
#>  1 Eye disorders 21 (10%)        16 (8%)         9 (4%)          3 (2%)         
#>  2 Social circu… 27 (14%)        12 (6%)         6 (3%)          4 (2%)         
#>  3 Congenital, … 23 (12%)        10 (5%)         4 (2%)          5 (2%)         
#>  4 Injury, pois… 17 (8%)         13 (6%)         3 (2%)          2 (1%)         
#>  5 Immune syste… 15 (8%)         9 (4%)          7 (4%)          3 (2%)         
#>  6 Pregnancy, p… 14 (7%)         12 (6%)         4 (2%)          3 (2%)         
#>  7 Neoplasms be… 12 (6%)         12 (6%)         4 (2%)          2 (1%)         
#>  8 Hepatobiliar… 17 (8%)         8 (4%)          1 (0%)          2 (1%)         
#>  9 Surgical and… 13 (6%)         10 (5%)         4 (2%)          1 (0%)         
#> 10 Cardiac diso… 11 (6%)         4 (2%)          7 (4%)          4 (2%)         
#> # ℹ 17 more rows
#> # ℹ 3 more variables: all_patients_G5 <glue>, all_patients_NA <glue>,
#> #   all_patients_Tot <glue>
ae_table_soc(df_ae=ae, df_enrol=enrolres, arm="arm")
#> # A tibble: 27 × 15
#>    soc         control_G1 control_G2 control_G3 control_G4 control_G5 control_NA
#>    <fct>       <glue>     <glue>     <glue>     <glue>     <glue>     <glue>    
#>  1 Eye disord… 14 (14%)   11 (11%)   4 (4%)     2 (2%)     NA         NA        
#>  2 Social cir… 16 (16%)   8 (8%)     3 (3%)     NA         NA         NA        
#>  3 Congenital… 10 (10%)   7 (7%)     2 (2%)     1 (1%)     NA         NA        
#>  4 Injury, po… 12 (12%)   8 (8%)     1 (1%)     1 (1%)     NA         NA        
#>  5 Immune sys… 8 (8%)     4 (4%)     4 (4%)     2 (2%)     NA         NA        
#>  6 Pregnancy,… 7 (7%)     5 (5%)     2 (2%)     2 (2%)     NA         NA        
#>  7 Neoplasms … 6 (6%)     7 (7%)     3 (3%)     1 (1%)     NA         NA        
#>  8 Hepatobili… 9 (9%)     3 (3%)     NA         2 (2%)     NA         NA        
#>  9 Surgical a… 6 (6%)     5 (5%)     2 (2%)     NA         NA         NA        
#> 10 Cardiac di… 7 (7%)     3 (3%)     4 (4%)     NA         NA         NA        
#> # ℹ 17 more rows
#> # ℹ 8 more variables: control_Tot <glue>, treatment_G1 <glue>,
#> #   treatment_G2 <glue>, treatment_G3 <glue>, treatment_G4 <glue>,
#> #   treatment_G5 <glue>, treatment_NA <glue>, treatment_Tot <glue>

#sub population
ae_table_soc(df_ae=ae, df_enrol=head(enrolres, 10), arm="arm")
#> # A tibble: 16 × 15
#>    soc         control_G1 control_G2 control_G3 control_G4 control_G5 control_NA
#>    <fct>       <glue>     <glue>     <glue>     <glue>     <glue>     <glue>    
#>  1 Eye disord… 3 (60%)    NA         1 (20%)    NA         NA         NA        
#>  2 Pregnancy,… 3 (60%)    1 (20%)    NA         NA         NA         NA        
#>  3 Psychiatri… 1 (20%)    NA         NA         NA         NA         NA        
#>  4 Social cir… 1 (20%)    NA         NA         NA         NA         NA        
#>  5 Cardiac di… NA         1 (20%)    NA         NA         NA         NA        
#>  6 Metabolism… 1 (20%)    NA         NA         NA         NA         NA        
#>  7 Neoplasms … NA         NA         2 (40%)    NA         NA         NA        
#>  8 Surgical a… NA         NA         NA         NA         NA         NA        
#>  9 Congenital… 1 (20%)    NA         NA         NA         NA         NA        
#> 10 Ear and la… 1 (20%)    NA         NA         NA         NA         NA        
#> 11 Infections… 1 (20%)    NA         NA         NA         NA         NA        
#> 12 Injury, po… NA         1 (20%)    NA         NA         NA         NA        
#> 13 Investigat… 1 (20%)    NA         NA         NA         NA         NA        
#> 14 Musculoske… NA         NA         1 (20%)    NA         NA         NA        
#> 15 Respirator… NA         NA         NA         NA         NA         NA        
#> 16 Vascular d… 1 (20%)    NA         NA         NA         NA         NA        
#> # ℹ 8 more variables: control_Tot <glue>, treatment_G1 <glue>,
#> #   treatment_G2 <glue>, treatment_G3 <glue>, treatment_G4 <glue>,
#> #   treatment_G5 <glue>, treatment_NA <glue>, treatment_Tot <glue>

#the resulting flextable can be customized using the flextable package
library(flextable)
ae_table_soc(ae, df_enrol=enrolres, total=FALSE) %>%
  as_flextable() %>%
  hline(i=~soc=="" & soc!=dplyr::lead(soc))
All patients (N=200)
CTCAE SOC G1 G2 G3 G4 G5 NA
Eye disorders 21 (10%) 16 (8%) 9 (4%) 3 (2%) 
Social circumstances 27 (14%) 12 (6%) 6 (3%) 4 (2%) 
Congenital, familial and genetic disorders 23 (12%) 10 (5%) 4 (2%) 5 (2%) 
Injury, poisoning and procedural complications 17 (8%) 13 (6%) 3 (2%) 2 (1%) 
Immune system disorders 15 (8%) 9 (4%) 7 (4%) 3 (2%) 
Pregnancy, puerperium and perinatal conditions 14 (7%) 12 (6%) 4 (2%) 3 (2%) 
Neoplasms benign, malignant, and unspecified 12 (6%) 12 (6%) 4 (2%) 2 (1%) 
Hepatobiliary disorders 17 (8%) 8 (4%) 1 (0%) 2 (1%) 
Surgical and medical procedures 13 (6%) 10 (5%) 4 (2%) 1 (0%) 
Cardiac disorders 11 (6%) 4 (2%) 7 (4%) 4 (2%) 
Respiratory, thoracic and mediastinal disorders 11 (6%) 6 (3%) 5 (2%) 1 (0%) 1 (0%) 
Ear and labyrinth disorders 7 (4%) 7 (4%) 4 (2%) 
Endocrine disorders 11 (6%) 2 (1%) 2 (1%) 1 (0%) 
Psychiatric disorders 10 (5%) 2 (1%) 3 (2%) 1 (0%) 
Vascular disorders 10 (5%) 3 (2%) 1 (0%) 2 (1%) 
Infections and infestations 10 (5%) 3 (2%) 1 (0%) 1 (0%) 
Musculoskeletal and connective tissue disorders 5 (2%) 3 (2%) 4 (2%) 1 (0%) 2 (1%) 
Nervous system disorders 5 (2%) 6 (3%) 1 (0%) 
Investigations 7 (4%) 1 (0%) 3 (2%) 
Blood and lymphatic system disorders 3 (2%) 3 (2%) 3 (2%) 1 (0%) 
Metabolism and nutrition disorders 8 (4%) 2 (1%) 
Skin and subcutaneous tissue disorders 6 (3%) 3 (2%) 1 (0%) 
General disorders and administration site conditions 2 (1%) 5 (2%) 2 (1%) 
Gastrointestinal disorders 5 (2%) 1 (0%) 1 (0%) 
Renal and urinary disorders 5 (2%) 1 (0%) 1 (0%) 
Reproductive system and breast disorders 3 (2%) 2 (1%) 2 (1%) 
No Declared AE 8 (4%)
ae_table_soc(ae, df_enrol=enrolres, term=NULL, sort_by_count=FALSE) %>%
  as_flextable() %>%
  bold(i=~soc=="Eye disorders")
All patients (N=200)
CTCAE SOC G1 G2 G3 G4 G5 NA Tot
Blood and lymphatic system disorders 3 (2%) 3 (2%) 3 (2%) 1 (0%) 10 (5%)
Cardiac disorders 11 (6%) 4 (2%) 7 (4%) 4 (2%) 26 (13%)
Congenital, familial and genetic disorders 23 (12%) 10 (5%) 4 (2%) 5 (2%) 42 (21%)
Ear and labyrinth disorders 7 (4%) 7 (4%) 4 (2%) 18 (9%)
Endocrine disorders 11 (6%) 2 (1%) 2 (1%) 1 (0%) 16 (8%)
Eye disorders 21 (10%) 16 (8%) 9 (4%) 3 (2%) 49 (24%)
Gastrointestinal disorders 5 (2%) 1 (0%) 1 (0%) 7 (4%)
General disorders and administration site conditions 2 (1%) 5 (2%) 2 (1%) 9 (4%)
Hepatobiliary disorders 17 (8%) 8 (4%) 1 (0%) 2 (1%) 28 (14%)
Immune system disorders 15 (8%) 9 (4%) 7 (4%) 3 (2%) 34 (17%)
Infections and infestations 10 (5%) 3 (2%) 1 (0%) 1 (0%) 15 (8%)
Injury, poisoning and procedural complications 17 (8%) 13 (6%) 3 (2%) 2 (1%) 35 (18%)
Investigations 7 (4%) 1 (0%) 3 (2%) 11 (6%)
Metabolism and nutrition disorders 8 (4%) 2 (1%) 10 (5%)
Musculoskeletal and connective tissue disorders 5 (2%) 3 (2%) 4 (2%) 1 (0%) 2 (1%) 15 (8%)
Neoplasms benign, malignant, and unspecified 12 (6%) 12 (6%) 4 (2%) 2 (1%) 30 (15%)
Nervous system disorders 5 (2%) 6 (3%) 1 (0%) 12 (6%)
Pregnancy, puerperium and perinatal conditions 14 (7%) 12 (6%) 4 (2%) 3 (2%) 33 (16%)
Psychiatric disorders 10 (5%) 2 (1%) 3 (2%) 1 (0%) 16 (8%)
Renal and urinary disorders 5 (2%) 1 (0%) 1 (0%) 7 (4%)
Reproductive system and breast disorders 3 (2%) 2 (1%) 2 (1%) 7 (4%)
Respiratory, thoracic and mediastinal disorders 11 (6%) 6 (3%) 5 (2%) 1 (0%) 1 (0%) 24 (12%)
Skin and subcutaneous tissue disorders 6 (3%) 3 (2%) 1 (0%) 10 (5%)
Social circumstances 27 (14%) 12 (6%) 6 (3%) 4 (2%) 49 (24%)
Surgical and medical procedures 13 (6%) 10 (5%) 4 (2%) 1 (0%) 28 (14%)
Vascular disorders 10 (5%) 3 (2%) 1 (0%) 2 (1%) 16 (8%)
No Declared AE 8 (4%) 8 (4%)
ae_table_soc(ae, df_enrol=enrolres, term="aeterm", arm=NULL) %>%
  as_flextable() %>%
  highlight(i=~soc=="Hepatobiliary disorders", j="all_patients_Tot")
All patients (N=200)
CTCAE SOC CTCAE v4.0 Term G1 G2 G3 G4 G5 NA Tot
Social circumstances Cultural issues 11 (6%) 3 (2%) 3 (2%) 2 (1%) 19 (10%)
Economic conditions affecting care 2 (1%) 4 (2%) 1 (0%) 7 (4%)
Family support issues 14 (7%) 4 (2%) 2 (1%) 20 (10%)
Social and environmental issues 7 (4%) 2 (1%) 2 (1%) 1 (0%) 12 (6%)
Eye disorders Corneal disorders 8 (4%) 3 (2%) 1 (0%) 12 (6%)
Eyelid disorders 5 (2%) 3 (2%) 2 (1%) 10 (5%)
Retinal disorders 6 (3%) 6 (3%) 4 (2%) 2 (1%) 18 (9%)
Vision disorders 6 (3%) 4 (2%) 2 (1%) 1 (0%) 13 (6%)
Congenital, familial and genetic disorders Chromosomal abnormalities 5 (2%) 2 (1%) 2 (1%) 3 (2%) 12 (6%)
Congenital nervous system disorders 10 (5%) 4 (2%) 14 (7%)
Familial hematologic disorders 5 (2%) 2 (1%) 1 (0%) 8 (4%)
Hereditary connective tissue disorders 8 (4%) 2 (1%) 2 (1%) 1 (0%) 13 (6%)
Injury, poisoning and procedural complications Poisonings 4 (2%) 4 (2%) 1 (0%) 9 (4%)
Procedural complications 12 (6%) 1 (0%) 2 (1%) 1 (0%) 16 (8%)
Radiation-related toxicities 2 (1%) 4 (2%) 1 (0%) 7 (4%)
Traumatic injuries 3 (2%) 4 (2%) 7 (4%)
Immune system disorders Autoimmune disorders 3 (2%) 1 (0%) 1 (0%) 1 (0%) 6 (3%)
Hypersensitivity conditions 7 (4%) 4 (2%) 2 (1%) 1 (0%) 14 (7%)
Immunodeficiency 2 (1%) 2 (1%) 2 (1%) 6 (3%)
Inflammatory responses 4 (2%) 4 (2%) 2 (1%) 1 (0%) 11 (6%)
Pregnancy, puerperium and perinatal conditions Breastfeeding issues 3 (2%) 2 (1%) 5 (2%)
Fetal complications 2 (1%) 7 (4%) 1 (0%) 2 (1%) 12 (6%)
Labor and delivery complications 6 (3%) 1 (0%) 2 (1%) 1 (0%) 10 (5%)
Pregnancy complications 4 (2%) 2 (1%) 1 (0%) 7 (4%)
Neoplasms benign, malignant, and unspecified Benign neoplasms 4 (2%) 7 (4%) 1 (0%) 1 (0%) 13 (6%)
Malignant neoplasms 2 (1%) 1 (0%) 3 (2%)
Neoplasms unspecified 1 (0%) 2 (1%) 2 (1%) 5 (2%)
Tumor progression 5 (2%) 3 (2%) 1 (0%) 1 (0%) 10 (5%)
Hepatobiliary disorders Bile duct disorders 4 (2%) 4 (2%) 1 (0%) 9 (4%)
Gallbladder disorders 4 (2%) 1 (0%) 1 (0%) 6 (3%)
Hepatic failure 5 (2%) 2 (1%) 7 (4%)
Liver disorders 6 (3%) 1 (0%) 1 (0%) 8 (4%)
Surgical and medical procedures Device implantation procedures 5 (2%) 1 (0%) 1 (0%) 7 (4%)
Diagnostic procedures 3 (2%) 3 (2%) 1 (0%) 7 (4%)
Surgical complications 3 (2%) 3 (2%) 2 (1%) 8 (4%)
Therapeutic procedures 3 (2%) 3 (2%) 1 (0%) 1 (0%) 8 (4%)
Cardiac disorders Cardiac arrhythmias 5 (2%) 2 (1%) 1 (0%) 1 (0%) 9 (4%)
Cardiac valve disorders 3 (2%) 1 (0%) 5 (2%) 2 (1%) 11 (6%)
Coronary artery disorders 3 (2%) 1 (0%) 4 (2%)
Heart failures 2 (1%) 1 (0%) 1 (0%) 4 (2%)
Respiratory, thoracic and mediastinal disorders Lung function disorders 2 (1%) 2 (1%) 3 (2%) 7 (4%)
Pleural disorders 3 (2%) 1 (0%) 1 (0%) 5 (2%)
Pulmonary vascular disorders 5 (2%) 1 (0%) 1 (0%) 7 (4%)
Respiratory infections 2 (1%) 3 (2%) 2 (1%) 7 (4%)
Ear and labyrinth disorders Hearing disorders 2 (1%) 1 (0%) 1 (0%) 4 (2%)
Labyrinth disorders 1 (0%) 2 (1%) 1 (0%) 4 (2%)
Tinnitus 2 (1%) 2 (1%) 2 (1%) 6 (3%)
Vertigo and balance disorders 2 (1%) 2 (1%) 4 (2%)
Endocrine disorders Adrenal gland disorders 3 (2%) 3 (2%)
Parathyroid gland disorders 3 (2%) 3 (2%)
Pituitary gland disorders 4 (2%) 1 (0%) 5 (2%)
Thyroid gland disorders 2 (1%) 1 (0%) 2 (1%) 1 (0%) 6 (3%)
Psychiatric disorders Anxiety disorders 2 (1%) 2 (1%) 1 (0%) 5 (2%)
Mood disorders 2 (1%) 2 (1%) 4 (2%)
Sleep disorders 4 (2%) 1 (0%) 5 (2%)
Substance-related disorders 3 (2%) 3 (2%)
Infections and infestations Bacterial infectious disorders 2 (1%) 2 (1%)
Fungal infectious disorders 1 (0%) 1 (0%) 2 (1%)
Parasitic infectious disorders 5 (2%) 2 (1%) 1 (0%) 8 (4%)
Viral infectious disorders 3 (2%) 1 (0%) 4 (2%)
Vascular disorders Hypertension-related conditions 2 (1%) 1 (0%) 3 (2%)
Hypotension-related conditions 3 (2%) 3 (2%)
Vascular hemorrhagic disorders 5 (2%) 1 (0%) 6 (3%)
Venous thromboembolic events 2 (1%) 1 (0%) 1 (0%) 4 (2%)
Musculoskeletal and connective tissue disorders Arthritis and joint disorders 2 (1%) 1 (0%) 3 (2%)
Bone disorders 1 (0%) 2 (1%) 1 (0%) 4 (2%)
Connective tissue disorders 3 (2%) 1 (0%) 1 (0%) 5 (2%)
Muscle disorders 2 (1%) 1 (0%) 3 (2%)
Nervous system disorders Headache disorders 3 (2%) 1 (0%) 1 (0%) 5 (2%)
Neurological disorders of the central nervous system 1 (0%) 2 (1%) 3 (2%)
Peripheral neuropathies 2 (1%) 2 (1%)
Seizure disorders 2 (1%) 1 (0%) 3 (2%)
Investigations Blood analyses 2 (1%) 1 (0%) 3 (2%)
Cardiovascular assessments 2 (1%) 1 (0%) 3 (2%)
Imaging studies 1 (0%) 1 (0%) 2 (1%)
Liver function analyses 3 (2%) 3 (2%)
Metabolism and nutrition disorders Fluid and electrolyte disorders 2 (1%) 2 (1%)
Lipid metabolism disorders 3 (2%) 3 (2%)
Nutritional disorders 2 (1%) 1 (0%) 3 (2%)
Vitamin deficiencies 2 (1%) 1 (0%) 3 (2%)
Blood and lymphatic system disorders Bone marrow disorders 1 (0%) 1 (0%)
Coagulation and bleeding analyses 1 (0%) 1 (0%)
Hematologic neoplasms 1 (0%) 1 (0%)
Red blood cell disorders 3 (2%) 3 (2%) 1 (0%) 7 (4%)
Skin and subcutaneous tissue disorders Dermatitis 2 (1%) 1 (0%) 3 (2%)
Skin and subcutaneous tissue injuries 1 (0%) 1 (0%) 2 (1%)
Skin infections 2 (1%) 2 (1%)
Skin pigmentation disorders 1 (0%) 1 (0%) 1 (0%) 3 (2%)
General disorders and administration site conditions General physical health deterioration 3 (2%) 3 (2%)
Injection site reactions 1 (0%) 1 (0%) 2 (1%) 4 (2%)
Pain and discomfort 1 (0%) 1 (0%) 2 (1%)
Gastrointestinal disorders Esophageal disorders 1 (0%) 1 (0%) 2 (1%)
Gastric disorders 2 (1%) 2 (1%)
Intestinal disorders 2 (1%) 1 (0%) 3 (2%)
Renal and urinary disorders Bladder disorders 1 (0%) 1 (0%)
Kidney disorders 2 (1%) 2 (1%)
Urethral disorders 1 (0%) 1 (0%) 2 (1%)
Urinary tract disorders 2 (1%) 2 (1%)
Reproductive system and breast disorders Breast disorders 1 (0%) 1 (0%)
Female reproductive disorders 1 (0%) 1 (0%) 2 (1%)
Male reproductive disorders 1 (0%) 2 (1%) 3 (2%)
Menstrual disorders 1 (0%) 1 (0%)
No Declared AE 8 (4%) 8 (4%)

	All patients (N=200)
CTCAE SOC	G1	G2	G3	G4	G5	NA
Eye disorders	21 (10%)	16 (8%)	9 (4%)	3 (2%)
Social circumstances	27 (14%)	12 (6%)	6 (3%)	4 (2%)
Congenital, familial and genetic disorders	23 (12%)	10 (5%)	4 (2%)	5 (2%)
Injury, poisoning and procedural complications	17 (8%)	13 (6%)	3 (2%)	2 (1%)
Immune system disorders	15 (8%)	9 (4%)	7 (4%)	3 (2%)
Pregnancy, puerperium and perinatal conditions	14 (7%)	12 (6%)	4 (2%)	3 (2%)
Neoplasms benign, malignant, and unspecified	12 (6%)	12 (6%)	4 (2%)	2 (1%)
Hepatobiliary disorders	17 (8%)	8 (4%)	1 (0%)	2 (1%)
Surgical and medical procedures	13 (6%)	10 (5%)	4 (2%)	1 (0%)
Cardiac disorders	11 (6%)	4 (2%)	7 (4%)	4 (2%)
Respiratory, thoracic and mediastinal disorders	11 (6%)	6 (3%)	5 (2%)	1 (0%)	1 (0%)
Ear and labyrinth disorders	7 (4%)	7 (4%)	4 (2%)
Endocrine disorders	11 (6%)	2 (1%)	2 (1%)	1 (0%)
Psychiatric disorders	10 (5%)	2 (1%)	3 (2%)	1 (0%)
Vascular disorders	10 (5%)	3 (2%)	1 (0%)	2 (1%)
Infections and infestations	10 (5%)	3 (2%)	1 (0%)		1 (0%)
Musculoskeletal and connective tissue disorders	5 (2%)	3 (2%)	4 (2%)	1 (0%)	2 (1%)
Nervous system disorders	5 (2%)	6 (3%)		1 (0%)
Investigations	7 (4%)	1 (0%)	3 (2%)
Blood and lymphatic system disorders	3 (2%)	3 (2%)	3 (2%)	1 (0%)
Metabolism and nutrition disorders	8 (4%)	2 (1%)
Skin and subcutaneous tissue disorders	6 (3%)	3 (2%)		1 (0%)
General disorders and administration site conditions	2 (1%)	5 (2%)	2 (1%)
Gastrointestinal disorders	5 (2%)	1 (0%)		1 (0%)
Renal and urinary disorders	5 (2%)		1 (0%)	1 (0%)
Reproductive system and breast disorders	3 (2%)	2 (1%)	2 (1%)
No Declared AE						8 (4%)

		All patients (N=200)
CTCAE SOC	CTCAE v4.0 Term	G1	G2	G3	G4	G5	NA	Tot
Social circumstances	Cultural issues	11 (6%)	3 (2%)	3 (2%)	2 (1%)			19 (10%)
	Economic conditions affecting care	2 (1%)	4 (2%)		1 (0%)			7 (4%)
	Family support issues	14 (7%)	4 (2%)	2 (1%)				20 (10%)
	Social and environmental issues	7 (4%)	2 (1%)	2 (1%)	1 (0%)			12 (6%)
Eye disorders	Corneal disorders	8 (4%)	3 (2%)	1 (0%)				12 (6%)
	Eyelid disorders	5 (2%)	3 (2%)	2 (1%)				10 (5%)
	Retinal disorders	6 (3%)	6 (3%)	4 (2%)	2 (1%)			18 (9%)
	Vision disorders	6 (3%)	4 (2%)	2 (1%)	1 (0%)			13 (6%)
Congenital, familial and genetic disorders	Chromosomal abnormalities	5 (2%)	2 (1%)	2 (1%)	3 (2%)			12 (6%)
	Congenital nervous system disorders	10 (5%)	4 (2%)					14 (7%)
	Familial hematologic disorders	5 (2%)	2 (1%)		1 (0%)			8 (4%)
	Hereditary connective tissue disorders	8 (4%)	2 (1%)	2 (1%)	1 (0%)			13 (6%)
Injury, poisoning and procedural complications	Poisonings	4 (2%)	4 (2%)	1 (0%)				9 (4%)
	Procedural complications	12 (6%)	1 (0%)	2 (1%)	1 (0%)			16 (8%)
	Radiation-related toxicities	2 (1%)	4 (2%)		1 (0%)			7 (4%)
	Traumatic injuries	3 (2%)	4 (2%)					7 (4%)
Immune system disorders	Autoimmune disorders	3 (2%)	1 (0%)	1 (0%)	1 (0%)			6 (3%)
	Hypersensitivity conditions	7 (4%)	4 (2%)	2 (1%)	1 (0%)			14 (7%)
	Immunodeficiency	2 (1%)	2 (1%)	2 (1%)				6 (3%)
	Inflammatory responses	4 (2%)	4 (2%)	2 (1%)	1 (0%)			11 (6%)
Pregnancy, puerperium and perinatal conditions	Breastfeeding issues	3 (2%)	2 (1%)					5 (2%)
	Fetal complications	2 (1%)	7 (4%)	1 (0%)	2 (1%)			12 (6%)
	Labor and delivery complications	6 (3%)	1 (0%)	2 (1%)	1 (0%)			10 (5%)
	Pregnancy complications	4 (2%)	2 (1%)	1 (0%)				7 (4%)
Neoplasms benign, malignant, and unspecified	Benign neoplasms	4 (2%)	7 (4%)	1 (0%)	1 (0%)			13 (6%)
	Malignant neoplasms	2 (1%)	1 (0%)					3 (2%)
	Neoplasms unspecified	1 (0%)	2 (1%)	2 (1%)				5 (2%)
	Tumor progression	5 (2%)	3 (2%)	1 (0%)	1 (0%)			10 (5%)
Hepatobiliary disorders	Bile duct disorders	4 (2%)	4 (2%)		1 (0%)			9 (4%)
	Gallbladder disorders	4 (2%)	1 (0%)		1 (0%)			6 (3%)
	Hepatic failure	5 (2%)	2 (1%)					7 (4%)
	Liver disorders	6 (3%)	1 (0%)	1 (0%)				8 (4%)
Surgical and medical procedures	Device implantation procedures	5 (2%)	1 (0%)	1 (0%)				7 (4%)
	Diagnostic procedures	3 (2%)	3 (2%)	1 (0%)				7 (4%)
	Surgical complications	3 (2%)	3 (2%)	2 (1%)				8 (4%)
	Therapeutic procedures	3 (2%)	3 (2%)	1 (0%)	1 (0%)			8 (4%)
Cardiac disorders	Cardiac arrhythmias	5 (2%)	2 (1%)	1 (0%)	1 (0%)			9 (4%)
	Cardiac valve disorders	3 (2%)	1 (0%)	5 (2%)	2 (1%)			11 (6%)
	Coronary artery disorders	3 (2%)			1 (0%)			4 (2%)
	Heart failures	2 (1%)	1 (0%)	1 (0%)				4 (2%)
Respiratory, thoracic and mediastinal disorders	Lung function disorders	2 (1%)	2 (1%)	3 (2%)				7 (4%)
	Pleural disorders	3 (2%)		1 (0%)		1 (0%)		5 (2%)
	Pulmonary vascular disorders	5 (2%)	1 (0%)		1 (0%)			7 (4%)
	Respiratory infections	2 (1%)	3 (2%)	2 (1%)				7 (4%)
Ear and labyrinth disorders	Hearing disorders	2 (1%)	1 (0%)	1 (0%)				4 (2%)
	Labyrinth disorders	1 (0%)	2 (1%)	1 (0%)				4 (2%)
	Tinnitus	2 (1%)	2 (1%)	2 (1%)				6 (3%)
	Vertigo and balance disorders	2 (1%)	2 (1%)					4 (2%)
Endocrine disorders	Adrenal gland disorders	3 (2%)						3 (2%)
	Parathyroid gland disorders	3 (2%)						3 (2%)
	Pituitary gland disorders	4 (2%)	1 (0%)					5 (2%)
	Thyroid gland disorders	2 (1%)	1 (0%)	2 (1%)	1 (0%)			6 (3%)
Psychiatric disorders	Anxiety disorders	2 (1%)	2 (1%)	1 (0%)				5 (2%)
	Mood disorders	2 (1%)		2 (1%)				4 (2%)
	Sleep disorders	4 (2%)			1 (0%)			5 (2%)
	Substance-related disorders	3 (2%)						3 (2%)
Infections and infestations	Bacterial infectious disorders	2 (1%)						2 (1%)
	Fungal infectious disorders	1 (0%)				1 (0%)		2 (1%)
	Parasitic infectious disorders	5 (2%)	2 (1%)	1 (0%)				8 (4%)
	Viral infectious disorders	3 (2%)	1 (0%)					4 (2%)
Vascular disorders	Hypertension-related conditions		2 (1%)	1 (0%)				3 (2%)
	Hypotension-related conditions	3 (2%)						3 (2%)
	Vascular hemorrhagic disorders	5 (2%)			1 (0%)			6 (3%)
	Venous thromboembolic events	2 (1%)	1 (0%)		1 (0%)			4 (2%)
Musculoskeletal and connective tissue disorders	Arthritis and joint disorders		2 (1%)			1 (0%)		3 (2%)
	Bone disorders		1 (0%)	2 (1%)		1 (0%)		4 (2%)
	Connective tissue disorders	3 (2%)		1 (0%)	1 (0%)			5 (2%)
	Muscle disorders	2 (1%)		1 (0%)				3 (2%)
Nervous system disorders	Headache disorders	3 (2%)	1 (0%)		1 (0%)			5 (2%)
	Neurological disorders of the central nervous system	1 (0%)	2 (1%)					3 (2%)
	Peripheral neuropathies		2 (1%)					2 (1%)
	Seizure disorders	2 (1%)	1 (0%)					3 (2%)
Investigations	Blood analyses	2 (1%)		1 (0%)				3 (2%)
	Cardiovascular assessments	2 (1%)		1 (0%)				3 (2%)
	Imaging studies		1 (0%)	1 (0%)				2 (1%)
	Liver function analyses	3 (2%)						3 (2%)
Metabolism and nutrition disorders	Fluid and electrolyte disorders	2 (1%)						2 (1%)
	Lipid metabolism disorders	3 (2%)						3 (2%)
	Nutritional disorders	2 (1%)	1 (0%)					3 (2%)
	Vitamin deficiencies	2 (1%)	1 (0%)					3 (2%)
Blood and lymphatic system disorders	Bone marrow disorders				1 (0%)			1 (0%)
	Coagulation and bleeding analyses			1 (0%)				1 (0%)
	Hematologic neoplasms			1 (0%)				1 (0%)
	Red blood cell disorders	3 (2%)	3 (2%)	1 (0%)				7 (4%)
Skin and subcutaneous tissue disorders	Dermatitis	2 (1%)	1 (0%)					3 (2%)
	Skin and subcutaneous tissue injuries	1 (0%)	1 (0%)					2 (1%)
	Skin infections	2 (1%)						2 (1%)
	Skin pigmentation disorders	1 (0%)	1 (0%)		1 (0%)			3 (2%)
General disorders and administration site conditions	General physical health deterioration		3 (2%)					3 (2%)
	Injection site reactions	1 (0%)	1 (0%)	2 (1%)				4 (2%)
	Pain and discomfort	1 (0%)	1 (0%)					2 (1%)
Gastrointestinal disorders	Esophageal disorders	1 (0%)			1 (0%)			2 (1%)
	Gastric disorders	2 (1%)						2 (1%)
	Intestinal disorders	2 (1%)	1 (0%)					3 (2%)
Renal and urinary disorders	Bladder disorders				1 (0%)			1 (0%)
	Kidney disorders	2 (1%)						2 (1%)
	Urethral disorders	1 (0%)		1 (0%)				2 (1%)
	Urinary tract disorders	2 (1%)						2 (1%)
Reproductive system and breast disorders	Breast disorders			1 (0%)				1 (0%)
	Female reproductive disorders	1 (0%)		1 (0%)				2 (1%)
	Male reproductive disorders	1 (0%)	2 (1%)					3 (2%)
	Menstrual disorders	1 (0%)						1 (0%)
No Declared AE							8 (4%)	8 (4%)

Usage

Arguments

Value

See also

Examples