Summary tables for AE by SOC

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

Usage

ae_table_soc(
  data_ae,
  ...,
  data_pat,
  measure = c("max", "sup", "eq"),
  group1 = "AESOC",
  group2 = NULL,
  arm = NULL,
  cols = c(grade = "AEGR", subjid = "SUBJID"),
  ae_groups = NULL,
  ae_label = "AE",
  sort_by_count = TRUE,
  total = TRUE,
  showNA = TRUE,
  digits = 0,
  warn_miss = FALSE
)

# S3 method for class 'ae_table_soc'
as_flextable(
  x,
  ...,
  show_footer = c("both", "explanation", "example", "none"),
  arm_colors = c("#f2dcdb", "#dbe5f1", "#ebf1dd", "#e5e0ec"),
  padding_v = NULL
)

Arguments

data_ae: adverse event dataset, one row per AE, containing subjid, grade, group1, and potentially group2.
...: unused
data_pat: enrollment dataset, one row per patient, containing subjid (and arm if needed). All patients should be in this dataset.
measure: 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.
group1, group2: name of the 1st and 2nd order grouping columns in data_ae. Case-insensitive. Use labels for the flextable output. Usually, group1 is the SOC and group2 the term, but it can be any other grouping variable. group2 can be set to NULL if not needed.
arm: name of the treatment column in data_pat. Case-insensitive. Can be set to NULL.
cols: a named character vector mapping column names. Should contain at least grade and subjid. Case-insensitive.
ae_groups: a named list specifying the grade values for each group.
ae_label: Label used in the output tables (e.g. "AE", "SAE", "Toxicity").
sort_by_count: whether to sort by the number of AE or by group1 alphabetically.
total: whether to add a total column for each arm.
showNA: whether to display missing grades. Only relevant if ae_groups is not used.
digits: significant digits for percentages.
warn_miss: whether to warn for missing values.
x: a dataframe, resulting of ae_table_soc()
show_footer: whether to show the footer with the explanation, the example, both, or none.
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)

#Default
ae_table_soc(data_ae=ae, data_pat=enrolres) %>%
  as_flextable()
All patients (N=200)
AE SOC G1 G2 G3 G4 G5 NA Tot
Eye disorders 21 (10%) 16 (8%) 9 (4%) 3 (2%) 49 (24%)
Social circumstances 27 (14%) 12 (6%) 6 (3%) 4 (2%) 49 (24%)
Congenital, familial and genetic disorders 23 (12%) 10 (5%) 4 (2%) 5 (2%) 42 (21%)
Injury, poisoning and procedural complications 17 (8%) 13 (6%) 3 (2%) 2 (1%) 35 (18%)
Immune system disorders 15 (8%) 9 (4%) 7 (4%) 3 (2%) 34 (17%)
Pregnancy, puerperium and perinatal conditions 14 (7%) 12 (6%) 4 (2%) 3 (2%) 33 (16%)
Neoplasms benign, malignant, and unspecified 12 (6%) 12 (6%) 4 (2%) 2 (1%) 30 (15%)
Hepatobiliary disorders 17 (8%) 8 (4%) 1 (0%) 2 (1%) 28 (14%)
Surgical and medical procedures 13 (6%) 10 (5%) 4 (2%) 1 (0%) 28 (14%)
Cardiac disorders 11 (6%) 4 (2%) 7 (4%) 4 (2%) 26 (13%)
Respiratory, thoracic and mediastinal disorders 11 (6%) 6 (3%) 5 (2%) 1 (0%) 1 (0%) 24 (12%)
Ear and labyrinth disorders 7 (4%) 7 (4%) 4 (2%) 18 (9%)
Endocrine disorders 11 (6%) 2 (1%) 2 (1%) 1 (0%) 16 (8%)
Psychiatric disorders 10 (5%) 2 (1%) 3 (2%) 1 (0%) 16 (8%)
Vascular disorders 10 (5%) 3 (2%) 1 (0%) 2 (1%) 16 (8%)
Infections and infestations 10 (5%) 3 (2%) 1 (0%) 1 (0%) 15 (8%)
Musculoskeletal and connective tissue disorders 5 (2%) 3 (2%) 4 (2%) 1 (0%) 2 (1%) 15 (8%)
Nervous system disorders 5 (2%) 6 (3%) 1 (0%) 12 (6%)
Investigations 7 (4%) 1 (0%) 3 (2%) 11 (6%)
Blood and lymphatic system disorders 3 (2%) 3 (2%) 3 (2%) 1 (0%) 10 (5%)
Metabolism and nutrition disorders 8 (4%) 2 (1%) 10 (5%)
Skin and subcutaneous tissue disorders 6 (3%) 3 (2%) 1 (0%) 10 (5%)
General disorders and administration site conditions 2 (1%) 5 (2%) 2 (1%) 9 (4%)
Gastrointestinal disorders 5 (2%) 1 (0%) 1 (0%) 7 (4%)
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%)
No Declared AE 8 (4%) 8 (4%)
Figures represent the number of patients who experienced an AE of maximum grade, for a given AE SOC.
For example, for AE with AE SOC "Eye disorders", the maximum grade was G2 for 16 (8%) patients.

#By arm, with alternative measure
ae_table_soc(data_ae=ae, data_pat=enrolres, arm="arm", measure="sup", total=FALSE) %>%
  as_flextable()
Control (N=100) Treatment (N=100)
AE SOC G1 G2 G3 G4 G5 NA G1 G2 G3 G4 G5 NA
Eye disorders 31 (31%) 17 (17%) 6 (6%) 2 (2%) 18 (18%) 11 (11%) 6 (6%) 1 (1%) 
Social circumstances 27 (27%) 11 (11%) 3 (3%) 22 (22%) 11 (11%) 7 (7%) 4 (4%) 
Congenital, familial and genetic disorders 20 (20%) 10 (10%) 3 (3%) 1 (1%) 22 (22%) 9 (9%) 6 (6%) 4 (4%) 
Immune system disorders 18 (18%) 10 (10%) 6 (6%) 2 (2%) 16 (16%) 9 (9%) 4 (4%) 1 (1%) 
Pregnancy, puerperium and perinatal conditions 16 (16%) 9 (9%) 4 (4%) 2 (2%) 17 (17%) 10 (10%) 3 (3%) 1 (1%) 
Injury, poisoning and procedural complications 22 (22%) 10 (10%) 2 (2%) 1 (1%) 13 (13%) 8 (8%) 3 (3%) 1 (1%) 
Cardiac disorders 14 (14%) 7 (7%) 4 (4%) 12 (12%) 8 (8%) 7 (7%) 4 (4%) 
Neoplasms benign, malignant, and unspecified 17 (17%) 11 (11%) 4 (4%) 1 (1%) 13 (13%) 7 (7%) 2 (2%) 1 (1%) 
Surgical and medical procedures 13 (13%) 7 (7%) 2 (2%) 15 (15%) 8 (8%) 3 (3%) 1 (1%) 
Respiratory, thoracic and mediastinal disorders 11 (11%) 4 (4%) 1 (1%) 13 (13%) 9 (9%) 6 (6%) 2 (2%) 1 (1%) 
Hepatobiliary disorders 14 (14%) 5 (5%) 2 (2%) 2 (2%) 14 (14%) 6 (6%) 1 (1%) 
Musculoskeletal and connective tissue disorders 11 (11%) 7 (7%) 5 (5%) 3 (3%) 2 (2%) 4 (4%) 3 (3%) 2 (2%) 
Ear and labyrinth disorders 8 (8%) 4 (4%) 2 (2%) 10 (10%) 7 (7%) 2 (2%) 
Psychiatric disorders 6 (6%) 2 (2%) 1 (1%) 10 (10%) 4 (4%) 3 (3%) 1 (1%) 
Vascular disorders 7 (7%) 1 (1%) 9 (9%) 5 (5%) 3 (3%) 2 (2%) 
Endocrine disorders 11 (11%) 2 (2%) 2 (2%) 1 (1%) 5 (5%) 3 (3%) 1 (1%) 
Infections and infestations 11 (11%) 3 (3%) 4 (4%) 2 (2%) 2 (2%) 1 (1%) 1 (1%) 
Blood and lymphatic system disorders 3 (3%) 3 (3%) 2 (2%) 1 (1%) 7 (7%) 4 (4%) 2 (2%) 
Nervous system disorders 5 (5%) 3 (3%) 7 (7%) 4 (4%) 1 (1%) 1 (1%) 
General disorders and administration site conditions 6 (6%) 6 (6%) 2 (2%) 3 (3%) 1 (1%) 
Investigations 7 (7%) 2 (2%) 1 (1%) 4 (4%) 2 (2%) 2 (2%) 
Skin and subcutaneous tissue disorders 4 (4%) 2 (2%) 1 (1%) 1 (1%) 6 (6%) 2 (2%) 
Reproductive system and breast disorders 3 (3%) 2 (2%) 1 (1%) 4 (4%) 2 (2%) 1 (1%) 
Metabolism and nutrition disorders 5 (5%) 1 (1%) 5 (5%) 1 (1%) 
Renal and urinary disorders 4 (4%) 1 (1%) 1 (1%) 3 (3%) 1 (1%) 1 (1%) 1 (1%) 
Gastrointestinal disorders 4 (4%) 2 (2%) 1 (1%) 1 (1%) 3 (3%) 
No Declared AE 
Figures represent the number of patients who experienced at least one AE of grade ≥ X, for a given arm and AE SOC.
For example, for AE in Control arm and with AE SOC "Eye disorders", at least one AE of grade ≥ G2 was reported for 17 (17%) patients.

#Sub-population, without footer
ae_table_soc(data_ae=ae, data_pat=head(enrolres, 10), arm="arm") %>%
  as_flextable(show_footer="none")
Control (N=5) Treatment (N=5)
AE SOC G1 G2 G3 G4 G5 NA Tot G1 G2 G3 G4 G5 NA Tot
Eye disorders 3 (60%) 1 (20%) 4 (80%) 1 (20%) 1 (20%)
Pregnancy, puerperium and perinatal conditions 3 (60%) 1 (20%) 4 (80%) 
Psychiatric disorders 1 (20%) 1 (20%) 1 (20%) 1 (20%) 2 (40%)
Social circumstances 1 (20%) 1 (20%) 1 (20%) 1 (20%) 2 (40%)
Cardiac disorders 1 (20%) 1 (20%) 1 (20%) 1 (20%)
Metabolism and nutrition disorders 1 (20%) 1 (20%) 1 (20%) 1 (20%)
Neoplasms benign, malignant, and unspecified 2 (40%) 2 (40%) 
Surgical and medical procedures 1 (20%) 1 (20%) 2 (40%)
Congenital, familial and genetic disorders 1 (20%) 1 (20%) 
Ear and labyrinth disorders 1 (20%) 1 (20%) 
Infections and infestations 1 (20%) 1 (20%) 
Injury, poisoning and procedural complications 1 (20%) 1 (20%) 
Investigations 1 (20%) 1 (20%) 
Musculoskeletal and connective tissue disorders 1 (20%) 1 (20%) 
Respiratory, thoracic and mediastinal disorders 1 (20%) 1 (20%)
Vascular disorders 1 (20%) 1 (20%) 

#Grouping grades, with only TERM
ae_groups = list("Any grade"=c(1:5,NA), "Grade 1-2"=1:2, "Grade 3-5"=3:5)
ae_table_soc(data_ae=ae, data_pat=head(enrolres, 10), group1="AETERM", ae_groups=ae_groups) %>%
  as_flextable()
All patients (N=10)
AE Term (HLGT) Any grade Grade 1-2 Grade 3-5 Tot
Cardiac arrhythmias 2 (20%) 2 (20%) 2 (20%)
Corneal disorders 2 (20%) 2 (20%) 2 (20%)
Cultural issues 2 (20%) 1 (10%) 1 (10%) 2 (20%)
Fetal complications 2 (20%) 2 (20%) 2 (20%)
Labor and delivery complications 2 (20%) 2 (20%) 2 (20%)
Retinal disorders 2 (20%) 1 (10%) 1 (10%) 2 (20%)
Substance-related disorders 2 (20%) 2 (20%) 2 (20%)
Therapeutic procedures 2 (20%) 1 (10%) 1 (10%) 2 (20%)
Benign neoplasms 1 (10%) 1 (10%) 1 (10%)
Cardiovascular assessments 1 (10%) 1 (10%) 1 (10%)
Connective tissue disorders 1 (10%) 1 (10%) 1 (10%)
Eyelid disorders 1 (10%) 1 (10%) 1 (10%)
Family support issues 1 (10%) 1 (10%) 1 (10%)
Fungal infectious disorders 1 (10%) 1 (10%) 1 (10%)
Hereditary connective tissue disorders 1 (10%) 1 (10%) 1 (10%)
Hypotension-related conditions 1 (10%) 1 (10%) 1 (10%)
Lung function disorders 1 (10%) 1 (10%) 1 (10%)
Mood disorders 1 (10%) 1 (10%) 1 (10%)
Neoplasms unspecified 1 (10%) 1 (10%) 1 (10%)
Nutritional disorders 1 (10%) 1 (10%) 1 (10%)
Procedural complications 1 (10%) 1 (10%) 1 (10%)
Social and environmental issues 1 (10%) 1 (10%) 1 (10%)
Surgical complications 1 (10%) 1 (10%) 1 (10%)
Tinnitus 1 (10%) 1 (10%) 1 (10%)
Vision disorders 1 (10%) 1 (10%) 1 (10%)
Vitamin deficiencies 1 (10%) 1 (10%) 1 (10%)
Figures represent the number of patients who experienced an AE of maximum grade, for a given AE Term (HLGT).
For example, for AE with AE Term (HLGT) "Cardiac arrhythmias", the maximum grade was Grade 1-2 for 2 (20%) patients.

#Stratified by both SOC and TERM
ae_table_soc(data_ae=ae, data_pat=head(enrolres, 10), arm="arm", 
             group1="AESOC", group2="AETERM") %>%
  dplyr::filter(!is.na(group2)) %>% #remove missing term
  as_flextable()
Control (N=5) Treatment (N=5)
AE SOC AE Term (HLGT) G1 G2 G3 G4 G5 NA Tot G1 G2 G3 G4 G5 NA Tot
Eye disorders Corneal disorders 2 (40%) 2 (40%) 
Eyelid disorders 1 (20%) 1 (20%)
Retinal disorders 1 (20%) 1 (20%) 2 (40%) 
Vision disorders 1 (20%) 1 (20%) 
Pregnancy, puerperium and perinatal conditions Fetal complications 1 (20%) 1 (20%) 2 (40%) 
Labor and delivery complications 2 (40%) 2 (40%) 
Social circumstances Cultural issues 1 (20%) 1 (20%) 1 (20%) 1 (20%)
Family support issues 1 (20%) 1 (20%)
Social and environmental issues 1 (20%) 1 (20%)
Psychiatric disorders Mood disorders 1 (20%) 1 (20%)
Substance-related disorders 1 (20%) 1 (20%) 1 (20%) 1 (20%)
Surgical and medical procedures Surgical complications 1 (20%) 1 (20%)
Therapeutic procedures 1 (20%) 1 (20%) 2 (40%)
Cardiac disorders Cardiac arrhythmias 1 (20%) 1 (20%) 1 (20%) 1 (20%)
Metabolism and nutrition disorders Nutritional disorders 1 (20%) 1 (20%) 
Vitamin deficiencies 1 (20%) 1 (20%)
Neoplasms benign, malignant, and unspecified Benign neoplasms 1 (20%) 1 (20%) 
Neoplasms unspecified 1 (20%) 1 (20%) 
Congenital, familial and genetic disorders Hereditary connective tissue disorders 1 (20%) 1 (20%) 
Ear and labyrinth disorders Tinnitus 1 (20%) 1 (20%) 
Infections and infestations Fungal infectious disorders 1 (20%) 1 (20%) 
Injury, poisoning and procedural complications Procedural complications 1 (20%) 1 (20%) 
Investigations Cardiovascular assessments 1 (20%) 1 (20%) 
Musculoskeletal and connective tissue disorders Connective tissue disorders 1 (20%) 1 (20%) 
Respiratory, thoracic and mediastinal disorders Lung function disorders 1 (20%) 1 (20%)
Vascular disorders Hypotension-related conditions 1 (20%) 1 (20%) 
Figures represent the number of patients who experienced an AE of maximum grade, for a given arm, AE SOC, and AE Term (HLGT).
For example, for AE in Control arm, with AE SOC "Pregnancy, puerperium and perinatal conditions", and AE Term (HLGT) "Fetal complications", the maximum grade was G2 for 1 (20%) patients.

	All patients (N=200)
AE SOC	G1	G2	G3	G4	G5	NA	Tot
Eye disorders	21 (10%)	16 (8%)	9 (4%)	3 (2%)			49 (24%)
Social circumstances	27 (14%)	12 (6%)	6 (3%)	4 (2%)			49 (24%)
Congenital, familial and genetic disorders	23 (12%)	10 (5%)	4 (2%)	5 (2%)			42 (21%)
Injury, poisoning and procedural complications	17 (8%)	13 (6%)	3 (2%)	2 (1%)			35 (18%)
Immune system disorders	15 (8%)	9 (4%)	7 (4%)	3 (2%)			34 (17%)
Pregnancy, puerperium and perinatal conditions	14 (7%)	12 (6%)	4 (2%)	3 (2%)			33 (16%)
Neoplasms benign, malignant, and unspecified	12 (6%)	12 (6%)	4 (2%)	2 (1%)			30 (15%)
Hepatobiliary disorders	17 (8%)	8 (4%)	1 (0%)	2 (1%)			28 (14%)
Surgical and medical procedures	13 (6%)	10 (5%)	4 (2%)	1 (0%)			28 (14%)
Cardiac disorders	11 (6%)	4 (2%)	7 (4%)	4 (2%)			26 (13%)
Respiratory, thoracic and mediastinal disorders	11 (6%)	6 (3%)	5 (2%)	1 (0%)	1 (0%)		24 (12%)
Ear and labyrinth disorders	7 (4%)	7 (4%)	4 (2%)				18 (9%)
Endocrine disorders	11 (6%)	2 (1%)	2 (1%)	1 (0%)			16 (8%)
Psychiatric disorders	10 (5%)	2 (1%)	3 (2%)	1 (0%)			16 (8%)
Vascular disorders	10 (5%)	3 (2%)	1 (0%)	2 (1%)			16 (8%)
Infections and infestations	10 (5%)	3 (2%)	1 (0%)		1 (0%)		15 (8%)
Musculoskeletal and connective tissue disorders	5 (2%)	3 (2%)	4 (2%)	1 (0%)	2 (1%)		15 (8%)
Nervous system disorders	5 (2%)	6 (3%)		1 (0%)			12 (6%)
Investigations	7 (4%)	1 (0%)	3 (2%)				11 (6%)
Blood and lymphatic system disorders	3 (2%)	3 (2%)	3 (2%)	1 (0%)			10 (5%)
Metabolism and nutrition disorders	8 (4%)	2 (1%)					10 (5%)
Skin and subcutaneous tissue disorders	6 (3%)	3 (2%)		1 (0%)			10 (5%)
General disorders and administration site conditions	2 (1%)	5 (2%)	2 (1%)				9 (4%)
Gastrointestinal disorders	5 (2%)	1 (0%)		1 (0%)			7 (4%)
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%)
No Declared AE						8 (4%)	8 (4%)
Figures represent the number of patients who experienced an AE of maximum grade, for a given AE SOC.
For example, for AE with AE SOC "Eye disorders", the maximum grade was G2 for 16 (8%) patients.

	Control (N=100)						Treatment (N=100)
AE SOC	G1	G2	G3	G4	G5	NA	G1	G2	G3	G4	G5	NA
Eye disorders	31 (31%)	17 (17%)	6 (6%)	2 (2%)			18 (18%)	11 (11%)	6 (6%)	1 (1%)
Social circumstances	27 (27%)	11 (11%)	3 (3%)				22 (22%)	11 (11%)	7 (7%)	4 (4%)
Congenital, familial and genetic disorders	20 (20%)	10 (10%)	3 (3%)	1 (1%)			22 (22%)	9 (9%)	6 (6%)	4 (4%)
Immune system disorders	18 (18%)	10 (10%)	6 (6%)	2 (2%)			16 (16%)	9 (9%)	4 (4%)	1 (1%)
Pregnancy, puerperium and perinatal conditions	16 (16%)	9 (9%)	4 (4%)	2 (2%)			17 (17%)	10 (10%)	3 (3%)	1 (1%)
Injury, poisoning and procedural complications	22 (22%)	10 (10%)	2 (2%)	1 (1%)			13 (13%)	8 (8%)	3 (3%)	1 (1%)
Cardiac disorders	14 (14%)	7 (7%)	4 (4%)				12 (12%)	8 (8%)	7 (7%)	4 (4%)
Neoplasms benign, malignant, and unspecified	17 (17%)	11 (11%)	4 (4%)	1 (1%)			13 (13%)	7 (7%)	2 (2%)	1 (1%)
Surgical and medical procedures	13 (13%)	7 (7%)	2 (2%)				15 (15%)	8 (8%)	3 (3%)	1 (1%)
Respiratory, thoracic and mediastinal disorders	11 (11%)	4 (4%)	1 (1%)				13 (13%)	9 (9%)	6 (6%)	2 (2%)	1 (1%)
Hepatobiliary disorders	14 (14%)	5 (5%)	2 (2%)	2 (2%)			14 (14%)	6 (6%)	1 (1%)
Musculoskeletal and connective tissue disorders	11 (11%)	7 (7%)	5 (5%)	3 (3%)	2 (2%)		4 (4%)	3 (3%)	2 (2%)
Ear and labyrinth disorders	8 (8%)	4 (4%)	2 (2%)				10 (10%)	7 (7%)	2 (2%)
Psychiatric disorders	6 (6%)	2 (2%)	1 (1%)				10 (10%)	4 (4%)	3 (3%)	1 (1%)
Vascular disorders	7 (7%)	1 (1%)					9 (9%)	5 (5%)	3 (3%)	2 (2%)
Endocrine disorders	11 (11%)	2 (2%)	2 (2%)	1 (1%)			5 (5%)	3 (3%)	1 (1%)
Infections and infestations	11 (11%)	3 (3%)					4 (4%)	2 (2%)	2 (2%)	1 (1%)	1 (1%)
Blood and lymphatic system disorders	3 (3%)	3 (3%)	2 (2%)	1 (1%)			7 (7%)	4 (4%)	2 (2%)
Nervous system disorders	5 (5%)	3 (3%)					7 (7%)	4 (4%)	1 (1%)	1 (1%)
General disorders and administration site conditions	6 (6%)	6 (6%)	2 (2%)				3 (3%)	1 (1%)
Investigations	7 (7%)	2 (2%)	1 (1%)				4 (4%)	2 (2%)	2 (2%)
Skin and subcutaneous tissue disorders	4 (4%)	2 (2%)	1 (1%)	1 (1%)			6 (6%)	2 (2%)
Reproductive system and breast disorders	3 (3%)	2 (2%)	1 (1%)				4 (4%)	2 (2%)	1 (1%)
Metabolism and nutrition disorders	5 (5%)	1 (1%)					5 (5%)	1 (1%)
Renal and urinary disorders	4 (4%)	1 (1%)	1 (1%)				3 (3%)	1 (1%)	1 (1%)	1 (1%)
Gastrointestinal disorders	4 (4%)	2 (2%)	1 (1%)	1 (1%)			3 (3%)
No Declared AE
Figures represent the number of patients who experienced at least one AE of grade ≥ X, for a given arm and AE SOC.
For example, for AE in Control arm and with AE SOC "Eye disorders", at least one AE of grade ≥ G2 was reported for 17 (17%) patients.

	Control (N=5)							Treatment (N=5)
AE SOC	G1	G2	G3	G4	G5	NA	Tot	G1	G2	G3	G4	G5	NA	Tot
Eye disorders	3 (60%)		1 (20%)				4 (80%)	1 (20%)						1 (20%)
Pregnancy, puerperium and perinatal conditions	3 (60%)	1 (20%)					4 (80%)
Psychiatric disorders	1 (20%)						1 (20%)	1 (20%)		1 (20%)				2 (40%)
Social circumstances	1 (20%)						1 (20%)			1 (20%)	1 (20%)			2 (40%)
Cardiac disorders		1 (20%)					1 (20%)	1 (20%)						1 (20%)
Metabolism and nutrition disorders	1 (20%)						1 (20%)	1 (20%)						1 (20%)
Neoplasms benign, malignant, and unspecified			2 (40%)				2 (40%)
Surgical and medical procedures									1 (20%)	1 (20%)				2 (40%)
Congenital, familial and genetic disorders	1 (20%)						1 (20%)
Ear and labyrinth disorders	1 (20%)						1 (20%)
Infections and infestations	1 (20%)						1 (20%)
Injury, poisoning and procedural complications		1 (20%)					1 (20%)
Investigations	1 (20%)						1 (20%)
Musculoskeletal and connective tissue disorders			1 (20%)				1 (20%)
Respiratory, thoracic and mediastinal disorders									1 (20%)					1 (20%)
Vascular disorders	1 (20%)						1 (20%)

	All patients (N=10)
AE Term (HLGT)	Any grade	Grade 1-2	Grade 3-5	Tot
Cardiac arrhythmias	2 (20%)	2 (20%)		2 (20%)
Corneal disorders	2 (20%)	2 (20%)		2 (20%)
Cultural issues	2 (20%)	1 (10%)	1 (10%)	2 (20%)
Fetal complications	2 (20%)	2 (20%)		2 (20%)
Labor and delivery complications	2 (20%)	2 (20%)		2 (20%)
Retinal disorders	2 (20%)	1 (10%)	1 (10%)	2 (20%)
Substance-related disorders	2 (20%)	2 (20%)		2 (20%)
Therapeutic procedures	2 (20%)	1 (10%)	1 (10%)	2 (20%)
Benign neoplasms	1 (10%)		1 (10%)	1 (10%)
Cardiovascular assessments	1 (10%)	1 (10%)		1 (10%)
Connective tissue disorders	1 (10%)		1 (10%)	1 (10%)
Eyelid disorders	1 (10%)	1 (10%)		1 (10%)
Family support issues	1 (10%)		1 (10%)	1 (10%)
Fungal infectious disorders	1 (10%)	1 (10%)		1 (10%)
Hereditary connective tissue disorders	1 (10%)	1 (10%)		1 (10%)
Hypotension-related conditions	1 (10%)	1 (10%)		1 (10%)
Lung function disorders	1 (10%)	1 (10%)		1 (10%)
Mood disorders	1 (10%)		1 (10%)	1 (10%)
Neoplasms unspecified	1 (10%)		1 (10%)	1 (10%)
Nutritional disorders	1 (10%)	1 (10%)		1 (10%)
Procedural complications	1 (10%)	1 (10%)		1 (10%)
Social and environmental issues	1 (10%)		1 (10%)	1 (10%)
Surgical complications	1 (10%)		1 (10%)	1 (10%)
Tinnitus	1 (10%)	1 (10%)		1 (10%)
Vision disorders	1 (10%)	1 (10%)		1 (10%)
Vitamin deficiencies	1 (10%)	1 (10%)		1 (10%)
Figures represent the number of patients who experienced an AE of maximum grade, for a given AE Term (HLGT).
For example, for AE with AE Term (HLGT) "Cardiac arrhythmias", the maximum grade was Grade 1-2 for 2 (20%) patients.

Usage

Arguments

Value

See also

Examples