1
Introduction
1.1
Tutorial: Subject-level graphs and tables
1.1.1
Scatter plots and spaghetti plots
1.1.2
Linked tables
1.2
Tutorial: Summarized visualizations.
1.2.1
Treemap graphs
1.2.2
Summary tables
2
Patient profiles
3
Alerts
3.1
Death
4
Subject disposition
4.1
Enrollment by country and site
4.1.1
Treemap visualization
4.2
Enrollment: cumulative number of randomizations
4.3
Demographics
5
Adverse events
5.1
Adverse events: summary table
5.2
Adverse events: summary table: comparison with previous data transfer
5.3
All adverse events: counts
5.3.1
Treemap visualization
5.3.2
Sunburst visualization
6
Adverse events: listing: comparison with previous data transfer
7
Adverse events: treatment-emergent time intervals
7.1
CARDIAC DISORDERS
7.1.1
ATRIAL FIBRILLATION
7.1.2
ATRIAL FLUTTER
7.1.3
ATRIAL HYPERTROPHY
7.1.4
ATRIOVENTRICULAR BLOCK FIRST DEGREE
7.1.5
ATRIOVENTRICULAR BLOCK SECOND DEGREE
7.1.6
BRADYCARDIA
7.1.7
BUNDLE BRANCH BLOCK LEFT
7.1.8
BUNDLE BRANCH BLOCK RIGHT
7.1.9
CARDIAC DISORDER
7.1.10
CARDIAC FAILURE CONGESTIVE
7.1.11
MYOCARDIAL INFARCTION
7.1.12
PALPITATIONS
7.1.13
SINUS ARRHYTHMIA
7.1.14
SINUS BRADYCARDIA
7.1.15
SUPRAVENTRICULAR EXTRASYSTOLES
7.1.16
SUPRAVENTRICULAR TACHYCARDIA
7.1.17
TACHYCARDIA
7.1.18
VENTRICULAR EXTRASYSTOLES
7.1.19
VENTRICULAR HYPERTROPHY
7.1.20
WOLFF-PARKINSON-WHITE SYNDROME
7.2
CONGENITAL, FAMILIAL AND GENETIC DISORDERS
7.2.1
VENTRICULAR SEPTAL DEFECT
7.3
EAR AND LABYRINTH DISORDERS
7.3.1
CERUMEN IMPACTION
7.3.2
EAR PAIN
7.3.3
VERTIGO
7.4
EYE DISORDERS
7.4.1
CONJUNCTIVAL HAEMORRHAGE
7.4.2
CONJUNCTIVITIS
7.4.3
EYE ALLERGY
7.4.4
EYE PRURITUS
7.4.5
EYE SWELLING
7.4.6
VISION BLURRED
7.5
GASTROINTESTINAL DISORDERS
7.5.1
ABDOMINAL DISCOMFORT
7.5.2
ABDOMINAL PAIN
7.5.3
CONSTIPATION
7.5.4
DIARRHOEA
7.5.5
DYSPEPSIA
7.5.6
DYSPHAGIA
7.5.7
FLATULENCE
7.5.8
GASTROINTESTINAL HAEMORRHAGE
7.5.9
GASTROOESOPHAGEAL REFLUX DISEASE
7.5.10
GLOSSITIS
7.5.11
HIATUS HERNIA
7.5.12
NAUSEA
7.5.13
RECTAL HAEMORRHAGE
7.5.14
SALIVARY HYPERSECRETION
7.5.15
STOMACH DISCOMFORT
7.5.16
VOMITING
7.6
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
7.6.1
APPLICATION SITE BLEEDING
7.6.2
APPLICATION SITE DERMATITIS
7.6.3
APPLICATION SITE DESQUAMATION
7.6.4
APPLICATION SITE DISCHARGE
7.6.5
APPLICATION SITE DISCOLOURATION
7.6.6
APPLICATION SITE ERYTHEMA
7.6.7
APPLICATION SITE INDURATION
7.6.8
APPLICATION SITE IRRITATION
7.6.9
APPLICATION SITE PAIN
7.6.10
APPLICATION SITE PERSPIRATION
7.6.11
APPLICATION SITE PRURITUS
7.6.12
APPLICATION SITE REACTION
7.6.13
APPLICATION SITE SWELLING
7.6.14
APPLICATION SITE URTICARIA
7.6.15
APPLICATION SITE VESICLES
7.6.16
APPLICATION SITE WARMTH
7.6.17
ASTHENIA
7.6.18
CHEST DISCOMFORT
7.6.19
CHEST PAIN
7.6.20
CHILLS
7.6.21
FATIGUE
7.6.22
FEELING ABNORMAL
7.6.23
FEELING COLD
7.6.24
INFLAMMATION
7.6.25
MALAISE
7.6.26
OEDEMA
7.6.27
OEDEMA PERIPHERAL
7.6.28
PAIN
7.6.29
PYREXIA
7.6.30
SECRETION DISCHARGE
7.6.31
SUDDEN DEATH
7.6.32
SWELLING
7.6.33
ULCER
7.7
HEPATOBILIARY DISORDERS
7.7.1
HYPERBILIRUBINAEMIA
7.8
IMMUNE SYSTEM DISORDERS
7.8.1
HYPERSENSITIVITY
7.9
INFECTIONS AND INFESTATIONS
7.9.1
BRONCHITIS
7.9.2
CELLULITIS
7.9.3
CERVICITIS
7.9.4
CYSTITIS
7.9.5
EAR INFECTION
7.9.6
GASTROENTERITIS VIRAL
7.9.7
INFLUENZA
7.9.8
LOCALISED INFECTION
7.9.9
LOWER RESPIRATORY TRACT INFECTION
7.9.10
NASOPHARYNGITIS
7.9.11
PNEUMONIA
7.9.12
RHINITIS
7.9.13
UPPER RESPIRATORY TRACT INFECTION
7.9.14
URINARY TRACT INFECTION
7.9.15
VAGINAL MYCOSIS
7.9.16
VIRAL INFECTION
7.10
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
7.10.1
CONTUSION
7.10.2
EXCORIATION
7.10.3
FACIAL BONES FRACTURE
7.10.4
FALL
7.10.5
HIP FRACTURE
7.10.6
JOINT DISLOCATION
7.10.7
SKIN LACERATION
7.10.8
WOUND
7.11
INVESTIGATIONS
7.11.1
BIOPSY
7.11.2
BIOPSY PROSTATE
7.11.3
BLOOD ALKALINE PHOSPHATASE INCREASED
7.11.4
BLOOD CHOLESTEROL INCREASED
7.11.5
BLOOD CREATINE PHOSPHOKINASE INCREASED
7.11.6
BLOOD GLUCOSE INCREASED
7.11.7
BLOOD URINE PRESENT
7.11.8
BODY TEMPERATURE INCREASED
7.11.9
CYSTOSCOPY
7.11.10
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION
7.11.11
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED
7.11.12
ELECTROCARDIOGRAM T WAVE INVERSION
7.11.13
HEART RATE INCREASED
7.11.14
HEART RATE IRREGULAR
7.11.15
NASAL MUCOSA BIOPSY
7.11.16
WEIGHT DECREASED
7.12
METABOLISM AND NUTRITION DISORDERS
7.12.1
DECREASED APPETITE
7.12.2
DEHYDRATION
7.12.3
DIABETES MELLITUS
7.12.4
FOOD CRAVING
7.12.5
HYPONATRAEMIA
7.12.6
INCREASED APPETITE
7.13
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
7.13.1
ARTHRALGIA
7.13.2
ARTHRITIS
7.13.3
BACK PAIN
7.13.4
FLANK PAIN
7.13.5
MUSCLE SPASMS
7.13.6
MUSCULAR WEAKNESS
7.13.7
MYALGIA
7.13.8
PAIN IN EXTREMITY
7.13.9
SHOULDER PAIN
7.14
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
7.14.1
COLON CANCER
7.14.2
MALIGNANT FIBROUS HISTIOCYTOMA
7.14.3
PROSTATE CANCER
7.15
NERVOUS SYSTEM DISORDERS
7.15.1
AMNESIA
7.15.2
BALANCE DISORDER
7.15.3
BURNING SENSATION
7.15.4
COGNITIVE DISORDER
7.15.5
COMPLEX PARTIAL SEIZURES
7.15.6
COORDINATION ABNORMAL
7.15.7
DIZZINESS
7.15.8
HEADACHE
7.15.9
HEMIANOPIA HOMONYMOUS
7.15.10
HYPERSOMNIA
7.15.11
LETHARGY
7.15.12
PARAESTHESIA
7.15.13
PARAESTHESIA ORAL
7.15.14
PARKINSON'S DISEASE
7.15.15
PAROSMIA
7.15.16
PARTIAL SEIZURES WITH SECONDARY GENERALISATION
7.15.17
PSYCHOMOTOR HYPERACTIVITY
7.15.18
SOMNOLENCE
7.15.19
STUPOR
7.15.20
SYNCOPE
7.15.21
SYNCOPE VASOVAGAL
7.15.22
TRANSIENT ISCHAEMIC ATTACK
7.16
PSYCHIATRIC DISORDERS
7.16.1
AGITATION
7.16.2
ANXIETY
7.16.3
COMPLETED SUICIDE
7.16.4
CONFUSIONAL STATE
7.16.5
DELIRIUM
7.16.6
DELUSION
7.16.7
DEPRESSED MOOD
7.16.8
DISORIENTATION
7.16.9
HALLUCINATION
7.16.10
HALLUCINATION, VISUAL
7.16.11
INSOMNIA
7.16.12
IRRITABILITY
7.16.13
LIBIDO DECREASED
7.16.14
LISTLESS
7.16.15
NIGHTMARE
7.16.16
RESTLESSNESS
7.17
RENAL AND URINARY DISORDERS
7.17.1
CALCULUS URETHRAL
7.17.2
DYSURIA
7.17.3
INCONTINENCE
7.17.4
MICTURITION URGENCY
7.17.5
NEPHROLITHIASIS
7.17.6
POLLAKIURIA
7.18
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
7.18.1
BENIGN PROSTATIC HYPERPLASIA
7.18.2
PELVIC PAIN
7.19
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
7.19.1
ALLERGIC GRANULOMATOUS ANGIITIS
7.19.2
COUGH
7.19.3
DYSPHONIA
7.19.4
DYSPNOEA
7.19.5
EMPHYSEMA
7.19.6
EPISTAXIS
7.19.7
HAEMOPTYSIS
7.19.8
NASAL CONGESTION
7.19.9
PHARYNGEAL ERYTHEMA
7.19.10
PHARYNGOLARYNGEAL PAIN
7.19.11
POSTNASAL DRIP
7.19.12
PRODUCTIVE COUGH
7.19.13
RALES
7.19.14
RESPIRATORY TRACT CONGESTION
7.19.15
RHINORRHOEA
7.20
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
7.20.1
ACTINIC KERATOSIS
7.20.2
ALOPECIA
7.20.3
BLISTER
7.20.4
COLD SWEAT
7.20.5
DERMATITIS CONTACT
7.20.6
DRUG ERUPTION
7.20.7
ERYTHEMA
7.20.8
HYPERHIDROSIS
7.20.9
PRURITUS
7.20.10
PRURITUS GENERALISED
7.20.11
RASH
7.20.12
RASH ERYTHEMATOUS
7.20.13
RASH MACULO-PAPULAR
7.20.14
RASH PRURITIC
7.20.15
SKIN EXFOLIATION
7.20.16
SKIN IRRITATION
7.20.17
SKIN ODOUR ABNORMAL
7.20.18
SKIN ULCER
7.20.19
URTICARIA
7.21
SOCIAL CIRCUMSTANCES
7.21.1
ALCOHOL USE
7.22
SURGICAL AND MEDICAL PROCEDURES
7.22.1
ACROCHORDON EXCISION
7.22.2
CATARACT OPERATION
7.22.3
EYE LASER SURGERY
7.22.4
SKIN LESION EXCISION
7.23
VASCULAR DISORDERS
7.23.1
HOT FLUSH
7.23.2
HYPERTENSION
7.23.3
HYPOTENSION
7.23.4
ORTHOSTATIC HYPOTENSION
7.23.5
WOUND HAEMORRHAGE
8
Concomitant medications
8.1
Concomitant medication: listing
9
Laboratory abnormalities: post-baseline patient counts per (ab)normality
10
Hepatoxicity (eDISH)
11
Laboratory profiles
11.1
Alanine Aminotransferase
11.2
Albumin
11.3
Alkaline Phosphatase
11.4
Anisocytes
11.5
Aspartate Aminotransferase
11.6
Basophils
11.7
Bilirubin
11.8
Blood Urea Nitrogen
11.9
Calcium
11.10
Chloride
11.11
Cholesterol
11.12
Creatine Kinase
11.13
Creatinine
11.14
Eosinophils
11.15
Ery Mean Corpuscular Hemoglobin
11.16
Ery Mean Corpuscular HGB Concentration
11.17
Ery Mean Corpuscular Volume
11.18
Erythrocytes
11.19
Gamma Glutamyl Transferase
11.20
Glucose
11.21
Hematocrit
11.22
Hemoglobin
11.23
Hemoglobin A1C
11.24
Ketones
11.25
Leukocytes
11.26
Lymphocytes
11.27
Macrocytes
11.28
Microcytes
11.29
Monocytes
11.30
pH
11.31
Phosphate
11.32
Platelet
11.33
Poikilocytes
11.34
Polychromasia
11.35
Potassium
11.36
Protein
11.37
Sodium
11.38
Specific Gravity
11.39
Thyrotropin
11.40
Urate
11.41
Urobilinogen
11.42
Vitamin B12
12
Laboratory profiles by visit
12.1
Alanine Aminotransferase
12.2
Albumin
12.3
Alkaline Phosphatase
12.4
Anisocytes
12.5
Aspartate Aminotransferase
12.6
Basophils
12.7
Bilirubin
12.8
Blood Urea Nitrogen
12.9
Calcium
12.10
Chloride
12.11
Cholesterol
12.12
Creatine Kinase
12.13
Creatinine
12.14
Eosinophils
12.15
Ery Mean Corpuscular Hemoglobin
12.16
Ery Mean Corpuscular HGB Concentration
12.17
Ery Mean Corpuscular Volume
12.18
Erythrocytes
12.19
Gamma Glutamyl Transferase
12.20
Glucose
12.21
Hematocrit
12.22
Hemoglobin
12.23
Hemoglobin A1C
12.24
Ketones
12.25
Leukocytes
12.26
Lymphocytes
12.27
Macrocytes
12.28
Microcytes
12.29
Monocytes
12.30
pH
12.31
Phosphate
12.32
Platelet
12.33
Poikilocytes
12.34
Polychromasia
12.35
Potassium
12.36
Protein
12.37
Sodium
12.38
Specific Gravity
12.39
Thyrotropin
12.40
Urate
12.41
Urobilinogen
12.42
Vitamin B12
13
Appendix
13.1
Session information
Clinical data review for the example study
12.31
Phosphate