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 Congenital, … 27 (14%)        15 (8%)         6 (3%)          3 (2%)         
#>  2 Social circu… 19 (10%)        14 (7%)         7 (4%)          5 (2%)         
#>  3 Surgical and… 26 (13%)        5 (2%)          8 (4%)          3 (2%)         
#>  4 Neoplasms be… 17 (8%)         11 (6%)         2 (1%)          7 (4%)         
#>  5 Eye disorders 19 (10%)        7 (4%)          7 (4%)          2 (1%)         
#>  6 Pregnancy, p… 18 (9%)         8 (4%)          7 (4%)          NA             
#>  7 Cardiac diso… 11 (6%)         8 (4%)          4 (2%)          5 (2%)         
#>  8 Injury, pois… 11 (6%)         9 (4%)          8 (4%)          1 (0%)         
#>  9 Immune syste… 15 (8%)         7 (4%)          3 (2%)          2 (1%)         
#> 10 Endocrine di… 10 (5%)         7 (4%)          4 (2%)          3 (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 Congenital… 18 (18%)   7 (7%)     2 (2%)     2 (2%)     NA         NA        
#>  2 Social cir… 13 (13%)   5 (5%)     3 (3%)     NA         NA         NA        
#>  3 Surgical a… 18 (18%)   2 (2%)     2 (2%)     NA         NA         NA        
#>  4 Neoplasms … 9 (9%)     5 (5%)     NA         3 (3%)     1 (1%)     NA        
#>  5 Eye disord… 7 (7%)     2 (2%)     3 (3%)     2 (2%)     NA         NA        
#>  6 Pregnancy,… 10 (10%)   2 (2%)     3 (3%)     NA         NA         NA        
#>  7 Cardiac di… 7 (7%)     5 (5%)     3 (3%)     2 (2%)     NA         NA        
#>  8 Injury, po… 6 (6%)     7 (7%)     4 (4%)     NA         NA         NA        
#>  9 Immune sys… 10 (10%)   3 (3%)     2 (2%)     NA         NA         NA        
#> 10 Endocrine … 4 (4%)     4 (4%)     2 (2%)     1 (1%)     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: 18 × 15
#>    soc         control_G1 control_G2 control_G3 control_G4 control_G5 control_NA
#>    <fct>       <glue>     <glue>     <glue>     <glue>     <glue>     <glue>    
#>  1 Congenital… 1 (20%)    NA         NA         NA         NA         NA        
#>  2 Injury, po… NA         1 (20%)    1 (20%)    NA         NA         NA        
#>  3 Surgical a… 1 (20%)    NA         NA         NA         NA         NA        
#>  4 Endocrine … NA         1 (20%)    NA         NA         NA         NA        
#>  5 Eye disord… 1 (20%)    NA         NA         NA         NA         NA        
#>  6 Investigat… 1 (20%)    NA         1 (20%)    NA         NA         NA        
#>  7 Neoplasms … NA         NA         NA         NA         NA         NA        
#>  8 Respirator… NA         NA         NA         NA         NA         NA        
#>  9 Cardiac di… NA         NA         NA         1 (20%)    NA         NA        
#> 10 Ear and la… NA         NA         NA         NA         NA         NA        
#> 11 General di… NA         NA         NA         NA         NA         NA        
#> 12 Hepatobili… NA         NA         NA         NA         NA         NA        
#> 13 Metabolism… NA         NA         NA         NA         NA         NA        
#> 14 Musculoske… NA         NA         NA         NA         NA         NA        
#> 15 Psychiatri… NA         1 (20%)    NA         NA         NA         NA        
#> 16 Skin and s… 1 (20%)    NA         NA         NA         NA         NA        
#> 17 Vascular d… 1 (20%)    NA         NA         NA         NA         NA        
#> 18 No Declare… NA         NA         NA         NA         NA         1 (20%)   
#> # 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
Congenital, familial and genetic disorders 27 (14%) 15 (8%) 6 (3%) 3 (2%) 
Social circumstances 19 (10%) 14 (7%) 7 (4%) 5 (2%) 
Surgical and medical procedures 26 (13%) 5 (2%) 8 (4%) 3 (2%) 1 (0%) 
Neoplasms benign, malignant, and unspecified 17 (8%) 11 (6%) 2 (1%) 7 (4%) 2 (1%) 
Eye disorders 19 (10%) 7 (4%) 7 (4%) 2 (1%) 
Pregnancy, puerperium and perinatal conditions 18 (9%) 8 (4%) 7 (4%) 
Cardiac disorders 11 (6%) 8 (4%) 4 (2%) 5 (2%) 2 (1%) 
Injury, poisoning and procedural complications 11 (6%) 9 (4%) 8 (4%) 1 (0%) 1 (0%) 
Immune system disorders 15 (8%) 7 (4%) 3 (2%) 2 (1%) 
Endocrine disorders 10 (5%) 7 (4%) 4 (2%) 3 (2%) 
Hepatobiliary disorders 13 (6%) 9 (4%) 1 (0%) 1 (0%) 
Psychiatric disorders 16 (8%) 3 (2%) 2 (1%) 2 (1%) 1 (0%) 
Vascular disorders 12 (6%) 5 (2%) 2 (1%) 2 (1%) 1 (0%) 
Musculoskeletal and connective tissue disorders 9 (4%) 5 (2%) 2 (1%) 5 (2%) 
Respiratory, thoracic and mediastinal disorders 8 (4%) 6 (3%) 2 (1%) 1 (0%) 1 (0%) 
Ear and labyrinth disorders 10 (5%) 5 (2%) 1 (0%) 
Metabolism and nutrition disorders 7 (4%) 3 (2%) 4 (2%) 
General disorders and administration site conditions 8 (4%) 3 (2%) 1 (0%) 
Nervous system disorders 7 (4%) 4 (2%) 1 (0%) 
Skin and subcutaneous tissue disorders 4 (2%) 5 (2%) 1 (0%) 2 (1%) 
Infections and infestations 6 (3%) 3 (2%) 1 (0%) 
Blood and lymphatic system disorders 6 (3%) 1 (0%) 1 (0%) 1 (0%) 
Gastrointestinal disorders 2 (1%) 2 (1%) 4 (2%) 1 (0%) 
Reproductive system and breast disorders 7 (4%) 2 (1%) 
Investigations 4 (2%) 2 (1%) 1 (0%) 1 (0%) 
Renal and urinary disorders 1 (0%) 3 (2%) 1 (0%) 1 (0%) 
No Declared AE 3 (2%)
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 6 (3%) 1 (0%) 1 (0%) 1 (0%) 9 (4%)
Cardiac disorders 11 (6%) 8 (4%) 4 (2%) 5 (2%) 2 (1%) 30 (15%)
Congenital, familial and genetic disorders 27 (14%) 15 (8%) 6 (3%) 3 (2%) 51 (26%)
Ear and labyrinth disorders 10 (5%) 5 (2%) 1 (0%) 16 (8%)
Endocrine disorders 10 (5%) 7 (4%) 4 (2%) 3 (2%) 24 (12%)
Eye disorders 19 (10%) 7 (4%) 7 (4%) 2 (1%) 35 (18%)
Gastrointestinal disorders 2 (1%) 2 (1%) 4 (2%) 1 (0%) 9 (4%)
General disorders and administration site conditions 8 (4%) 3 (2%) 1 (0%) 12 (6%)
Hepatobiliary disorders 13 (6%) 9 (4%) 1 (0%) 1 (0%) 24 (12%)
Immune system disorders 15 (8%) 7 (4%) 3 (2%) 2 (1%) 27 (14%)
Infections and infestations 6 (3%) 3 (2%) 1 (0%) 10 (5%)
Injury, poisoning and procedural complications 11 (6%) 9 (4%) 8 (4%) 1 (0%) 1 (0%) 30 (15%)
Investigations 4 (2%) 2 (1%) 1 (0%) 1 (0%) 8 (4%)
Metabolism and nutrition disorders 7 (4%) 3 (2%) 4 (2%) 14 (7%)
Musculoskeletal and connective tissue disorders 9 (4%) 5 (2%) 2 (1%) 5 (2%) 21 (10%)
Neoplasms benign, malignant, and unspecified 17 (8%) 11 (6%) 2 (1%) 7 (4%) 2 (1%) 39 (20%)
Nervous system disorders 7 (4%) 4 (2%) 1 (0%) 12 (6%)
Pregnancy, puerperium and perinatal conditions 18 (9%) 8 (4%) 7 (4%) 33 (16%)
Psychiatric disorders 16 (8%) 3 (2%) 2 (1%) 2 (1%) 1 (0%) 24 (12%)
Renal and urinary disorders 1 (0%) 3 (2%) 1 (0%) 1 (0%) 6 (3%)
Reproductive system and breast disorders 7 (4%) 2 (1%) 9 (4%)
Respiratory, thoracic and mediastinal disorders 8 (4%) 6 (3%) 2 (1%) 1 (0%) 1 (0%) 18 (9%)
Skin and subcutaneous tissue disorders 4 (2%) 5 (2%) 1 (0%) 2 (1%) 12 (6%)
Social circumstances 19 (10%) 14 (7%) 7 (4%) 5 (2%) 45 (22%)
Surgical and medical procedures 26 (13%) 5 (2%) 8 (4%) 3 (2%) 1 (0%) 43 (22%)
Vascular disorders 12 (6%) 5 (2%) 2 (1%) 2 (1%) 1 (0%) 22 (11%)
No Declared AE 3 (2%) 3 (2%)
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
Congenital, familial and genetic disorders Chromosomal abnormalities 11 (6%) 5 (2%) 1 (0%) 1 (0%) 18 (9%)
Congenital nervous system disorders 6 (3%) 3 (2%) 9 (4%)
Familial hematologic disorders 7 (4%) 1 (0%) 3 (2%) 2 (1%) 13 (6%)
Hereditary connective tissue disorders 9 (4%) 6 (3%) 2 (1%) 17 (8%)
Social circumstances Cultural issues 5 (2%) 2 (1%) 2 (1%) 1 (0%) 10 (5%)
Economic conditions affecting care 3 (2%) 4 (2%) 1 (0%) 1 (0%) 9 (4%)
Family support issues 6 (3%) 3 (2%) 3 (2%) 2 (1%) 14 (7%)
Social and environmental issues 7 (4%) 5 (2%) 1 (0%) 1 (0%) 14 (7%)
Surgical and medical procedures Device implantation procedures 13 (6%) 1 (0%) 2 (1%) 1 (0%) 17 (8%)
Diagnostic procedures 10 (5%) 1 (0%) 5 (2%) 16 (8%)
Surgical complications 3 (2%) 4 (2%) 1 (0%) 1 (0%) 9 (4%)
Therapeutic procedures 2 (1%) 1 (0%) 3 (2%)
Neoplasms benign, malignant, and unspecified Benign neoplasms 5 (2%) 4 (2%) 1 (0%) 3 (2%) 13 (6%)
Malignant neoplasms 6 (3%) 4 (2%) 1 (0%) 2 (1%) 13 (6%)
Neoplasms unspecified 5 (2%) 1 (0%) 1 (0%) 7 (4%)
Tumor progression 2 (1%) 3 (2%) 1 (0%) 1 (0%) 7 (4%)
Eye disorders Corneal disorders 4 (2%) 2 (1%) 2 (1%) 8 (4%)
Eyelid disorders 6 (3%) 1 (0%) 1 (0%) 8 (4%)
Retinal disorders 5 (2%) 2 (1%) 2 (1%) 9 (4%)
Vision disorders 7 (4%) 4 (2%) 2 (1%) 13 (6%)
Pregnancy, puerperium and perinatal conditions Breastfeeding issues 4 (2%) 1 (0%) 2 (1%) 7 (4%)
Fetal complications 3 (2%) 2 (1%) 2 (1%) 7 (4%)
Labor and delivery complications 7 (4%) 4 (2%) 1 (0%) 12 (6%)
Pregnancy complications 5 (2%) 1 (0%) 2 (1%) 8 (4%)
Injury, poisoning and procedural complications Poisonings 3 (2%) 3 (2%) 1 (0%) 1 (0%) 1 (0%) 9 (4%)
Procedural complications 2 (1%) 3 (2%) 2 (1%) 7 (4%)
Radiation-related toxicities 2 (1%) 3 (2%) 2 (1%) 7 (4%)
Traumatic injuries 6 (3%) 1 (0%) 3 (2%) 10 (5%)
Cardiac disorders Cardiac arrhythmias 5 (2%) 2 (1%) 2 (1%) 9 (4%)
Cardiac valve disorders 2 (1%) 1 (0%) 2 (1%) 1 (0%) 2 (1%) 8 (4%)
Coronary artery disorders 1 (0%) 4 (2%) 1 (0%) 1 (0%) 7 (4%)
Heart failures 5 (2%) 1 (0%) 1 (0%) 1 (0%) 8 (4%)
Immune system disorders Autoimmune disorders 6 (3%) 1 (0%) 1 (0%) 8 (4%)
Hypersensitivity conditions 4 (2%) 1 (0%) 1 (0%) 1 (0%) 7 (4%)
Immunodeficiency 3 (2%) 1 (0%) 4 (2%)
Inflammatory responses 4 (2%) 5 (2%) 2 (1%) 11 (6%)
Endocrine disorders Adrenal gland disorders 2 (1%) 5 (2%) 7 (4%)
Parathyroid gland disorders 1 (0%) 3 (2%) 1 (0%) 5 (2%)
Pituitary gland disorders 6 (3%) 2 (1%) 1 (0%) 9 (4%)
Thyroid gland disorders 3 (2%) 1 (0%) 2 (1%) 6 (3%)
Psychiatric disorders Anxiety disorders 5 (2%) 5 (2%)
Mood disorders 2 (1%) 1 (0%) 3 (2%)
Sleep disorders 8 (4%) 1 (0%) 9 (4%)
Substance-related disorders 2 (1%) 2 (1%) 2 (1%) 1 (0%) 1 (0%) 8 (4%)
Hepatobiliary disorders Bile duct disorders 4 (2%) 3 (2%) 7 (4%)
Gallbladder disorders 3 (2%) 2 (1%) 5 (2%)
Hepatic failure 3 (2%) 2 (1%) 1 (0%) 1 (0%) 7 (4%)
Liver disorders 3 (2%) 2 (1%) 5 (2%)
Vascular disorders Hypertension-related conditions 4 (2%) 2 (1%) 1 (0%) 7 (4%)
Hypotension-related conditions 4 (2%) 1 (0%) 1 (0%) 6 (3%)
Vascular hemorrhagic disorders 1 (0%) 2 (1%) 1 (0%) 1 (0%) 5 (2%)
Venous thromboembolic events 3 (2%) 1 (0%) 1 (0%) 5 (2%)
Musculoskeletal and connective tissue disorders Arthritis and joint disorders 6 (3%) 1 (0%) 1 (0%) 8 (4%)
Bone disorders 2 (1%) 1 (0%) 2 (1%) 5 (2%)
Connective tissue disorders 1 (0%) 2 (1%) 1 (0%) 2 (1%) 6 (3%)
Muscle disorders 2 (1%) 1 (0%) 3 (2%)
Ear and labyrinth disorders Hearing disorders 2 (1%) 1 (0%) 3 (2%)
Labyrinth disorders 1 (0%) 1 (0%)
Tinnitus 6 (3%) 1 (0%) 7 (4%)
Vertigo and balance disorders 3 (2%) 4 (2%) 7 (4%)
Respiratory, thoracic and mediastinal disorders Lung function disorders 3 (2%) 3 (2%) 6 (3%)
Pleural disorders 1 (0%) 1 (0%) 1 (0%) 1 (0%) 4 (2%)
Pulmonary vascular disorders 3 (2%) 2 (1%) 1 (0%) 6 (3%)
Respiratory infections 1 (0%) 1 (0%) 2 (1%)
Metabolism and nutrition disorders Fluid and electrolyte disorders 2 (1%) 1 (0%) 1 (0%) 4 (2%)
Lipid metabolism disorders 1 (0%) 1 (0%) 2 (1%)
Nutritional disorders 4 (2%) 4 (2%)
Vitamin deficiencies 1 (0%) 1 (0%) 2 (1%) 4 (2%)
Nervous system disorders Headache disorders 3 (2%) 2 (1%) 5 (2%)
Neurological disorders of the central nervous system 3 (2%) 1 (0%) 4 (2%)
Peripheral neuropathies 1 (0%) 1 (0%)
Seizure disorders 2 (1%) 1 (0%) 3 (2%)
General disorders and administration site conditions Device issues 4 (2%) 1 (0%) 5 (2%)
General physical health deterioration 3 (2%) 3 (2%)
Injection site reactions 1 (0%) 1 (0%) 2 (1%)
Pain and discomfort 2 (1%) 2 (1%)
Skin and subcutaneous tissue disorders Dermatitis 1 (0%) 1 (0%) 1 (0%) 3 (2%)
Skin and subcutaneous tissue injuries 1 (0%) 2 (1%) 3 (2%)
Skin infections 2 (1%) 2 (1%) 1 (0%) 5 (2%)
Skin pigmentation disorders 1 (0%) 1 (0%)
Infections and infestations Bacterial infectious disorders 1 (0%) 1 (0%)
Fungal infectious disorders 1 (0%) 1 (0%)
Parasitic infectious disorders 2 (1%) 1 (0%) 3 (2%)
Viral infectious disorders 3 (2%) 2 (1%) 5 (2%)
Blood and lymphatic system disorders Bone marrow disorders 1 (0%) 1 (0%)
Hematologic neoplasms 4 (2%) 1 (0%) 1 (0%) 6 (3%)
Red blood cell disorders 1 (0%) 1 (0%) 2 (1%)
Gastrointestinal disorders Esophageal disorders 1 (0%) 1 (0%)
Gastric disorders 2 (1%) 1 (0%) 2 (1%) 5 (2%)
Intestinal disorders 1 (0%) 2 (1%) 3 (2%)
Reproductive system and breast disorders Breast disorders 2 (1%) 2 (1%)
Female reproductive disorders 2 (1%) 2 (1%)
Male reproductive disorders 2 (1%) 2 (1%) 4 (2%)
Menstrual disorders 1 (0%) 1 (0%)
Investigations Blood analyses 1 (0%) 1 (0%) 2 (1%)
Cardiovascular assessments 2 (1%) 2 (1%)
Imaging studies 1 (0%) 1 (0%) 2 (1%)
Liver function analyses 1 (0%) 1 (0%) 2 (1%)
Renal and urinary disorders Bladder disorders 1 (0%) 1 (0%) 2 (1%)
Kidney disorders 1 (0%) 1 (0%) 1 (0%) 3 (2%)
Urinary tract disorders 1 (0%) 1 (0%)
No Declared AE 3 (2%) 3 (2%)

	All patients (N=200)
CTCAE SOC	G1	G2	G3	G4	G5	NA
Congenital, familial and genetic disorders	27 (14%)	15 (8%)	6 (3%)	3 (2%)
Social circumstances	19 (10%)	14 (7%)	7 (4%)	5 (2%)
Surgical and medical procedures	26 (13%)	5 (2%)	8 (4%)	3 (2%)	1 (0%)
Neoplasms benign, malignant, and unspecified	17 (8%)	11 (6%)	2 (1%)	7 (4%)	2 (1%)
Eye disorders	19 (10%)	7 (4%)	7 (4%)	2 (1%)
Pregnancy, puerperium and perinatal conditions	18 (9%)	8 (4%)	7 (4%)
Cardiac disorders	11 (6%)	8 (4%)	4 (2%)	5 (2%)	2 (1%)
Injury, poisoning and procedural complications	11 (6%)	9 (4%)	8 (4%)	1 (0%)	1 (0%)
Immune system disorders	15 (8%)	7 (4%)	3 (2%)	2 (1%)
Endocrine disorders	10 (5%)	7 (4%)	4 (2%)	3 (2%)
Hepatobiliary disorders	13 (6%)	9 (4%)	1 (0%)	1 (0%)
Psychiatric disorders	16 (8%)	3 (2%)	2 (1%)	2 (1%)	1 (0%)
Vascular disorders	12 (6%)	5 (2%)	2 (1%)	2 (1%)	1 (0%)
Musculoskeletal and connective tissue disorders	9 (4%)	5 (2%)	2 (1%)	5 (2%)
Respiratory, thoracic and mediastinal disorders	8 (4%)	6 (3%)	2 (1%)	1 (0%)	1 (0%)
Ear and labyrinth disorders	10 (5%)	5 (2%)	1 (0%)
Metabolism and nutrition disorders	7 (4%)	3 (2%)	4 (2%)
General disorders and administration site conditions	8 (4%)	3 (2%)		1 (0%)
Nervous system disorders	7 (4%)	4 (2%)		1 (0%)
Skin and subcutaneous tissue disorders	4 (2%)	5 (2%)	1 (0%)	2 (1%)
Infections and infestations	6 (3%)	3 (2%)		1 (0%)
Blood and lymphatic system disorders	6 (3%)	1 (0%)	1 (0%)		1 (0%)
Gastrointestinal disorders	2 (1%)	2 (1%)	4 (2%)	1 (0%)
Reproductive system and breast disorders	7 (4%)	2 (1%)
Investigations	4 (2%)	2 (1%)	1 (0%)	1 (0%)
Renal and urinary disorders	1 (0%)	3 (2%)	1 (0%)	1 (0%)
No Declared AE						3 (2%)

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

Usage

Arguments

Value

See also

Examples