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
3.2
Death: comparison with previous data transfer
4
Subject disposition
4.1
Enrollment by country
4.1.1
Sunburst visualization
4.2
Enrollment: cumulative number of randomizations
4.3
Demographics
4.4
Discontinuation listing
4.5
Subject disposition: summary table
5
Inclusion / exclusion: listing
6
Adverse events
6.1
Adverse events: summary table
6.2
Adverse events: comparison with previous data transfer
6.3
All adverse events: counts
6.3.1
Treemap visualization
6.3.2
Sunburst visualization
6.4
Adverse events: listing
6.5
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
Hepatoxicity (eDISH)
8.1
eDISH: AST vs bilirubin
8.2
eDISH: ALT vs bilirubin
9
Laboratory abnormalities: post-baseline patient counts per (ab)normality
10
Laboratory parameters: time profiles
10.1
Alanine Aminotransferase
10.2
Albumin
10.3
Alkaline Phosphatase
10.4
Anisocytes
10.5
Aspartate Aminotransferase
10.6
Basophils
10.7
Bilirubin
10.8
Blood Urea Nitrogen
10.9
Calcium
10.10
Chloride
10.11
Cholesterol
10.12
Creatine Kinase
10.13
Creatinine
10.14
Eosinophils
10.15
Ery Mean Corpuscular Hemoglobin
10.16
Ery Mean Corpuscular HGB Concentration
10.17
Ery Mean Corpuscular Volume
10.18
Erythrocytes
10.19
Gamma Glutamyl Transferase
10.20
Glucose
10.21
Hematocrit
10.22
Hemoglobin
10.23
Hemoglobin A1C
10.24
Ketones
10.25
Leukocytes
10.26
Lymphocytes
10.27
Macrocytes
10.28
Microcytes
10.29
Monocytes
10.30
pH
10.31
Phosphate
10.32
Platelet
10.33
Poikilocytes
10.34
Polychromasia
10.35
Potassium
10.36
Protein
10.37
Sodium
10.38
Specific Gravity
10.39
Thyrotropin
10.40
Urate
10.41
Urobilinogen
10.42
Vitamin B12
11
Laboratory abnormal results listing
12
Vital signs: Baseline summary table
13
Vital signs: time profiles
13.1
Diastolic Blood Pressure
13.2
Height
13.3
Pulse Rate
13.4
Systolic Blood Pressure
13.5
Temperature
13.6
Weight
14
Concomitant medication: listing
15
Concomitant medication changes during study: time intervals
15.1
ALIMENTARY TRACT AND METABOLISM
15.1.1
ALGELDRATE
15.1.2
CIMETIDINE
15.1.3
LOPERAMIDE HYDROCHLORIDE
15.1.4
NIZATIDINE
15.2
CARDIOVASCULAR SYSTEM
15.2.1
AMLODIPINE
15.2.2
DIGOXIN
15.2.3
DILTIAZEM HYDROCHLORIDE
15.2.4
DOXAZOSIN MESILATE
15.2.5
FUROSEMIDE
15.2.6
LOSARTAN POTASSIUM
15.2.7
NIFEDIPINE
15.3
DERMATOLOGICALS
15.3.1
CLOBETASOL PROPIONATE
15.4
GENITO URINARY SYSTEM AND SEX HORMONES
15.4.1
ESTROGENS CONJUGATED
15.5
NERVOUS SYSTEM
15.5.1
ACETYLSALICYLIC ACID
15.5.2
DONEPEZIL HYDROCHLORIDE
15.5.3
HALOPERIDOL
15.5.4
PAROXETINE HYDROCHLORIDE
15.6
RESPIRATORY SYSTEM
15.6.1
BUDESONIDE
15.6.2
GUAIFENESIN
15.6.3
SALBUTAMOL SULFATE
15.7
SYSTEMIC HORMONAL PREPARATIONS, EXCL
15.7.1
HYDROCORTISONE
15.8
UNCODED
15.8.1
UNCODED
16
Medical history: listing
17
Appendix
17.1
Session information
Medical monitoring report
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