Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 4:15 AM
Ignite Modification Date: 2025-12-26 @ 3:14 AM
NCT ID: NCT01794520
Description: TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
Frequency Threshold: 5
Time Frame: All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
Study: NCT01794520
Study Brief: Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase 1: Venetoclax 300 mg Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly. 1 None 1 6 6 6 View
Phase 1: Venetoclax 600 mg Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly. 1 None 4 9 9 9 View
Phase 1: Venetoclax 900 mg Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly. 1 None 3 6 6 6 View
Phase 1: Venetoclax 1200 mg Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly. 0 None 3 9 9 9 View
Phase 1 Safety Expansion: Venetoclax 1200 mg Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly. 6 None 15 36 35 36 View
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years). 1 None 6 20 19 20 View
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years). 22 None 16 31 27 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
HYPERVISCOSITY SYNDROME SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
SUPRAVENTRICULAR TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
OESOPHAGITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
CHEST DISCOMFORT SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
ANAPHYLACTIC REACTION SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
ABSCESS BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
ABSCESS INTESTINAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
CANDIDA INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
CLOSTRIDIUM DIFFICILE COLITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
CLOSTRIDIUM DIFFICILE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
DIVERTICULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
ENTEROBACTER SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
ENTEROCOCCAL SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
ENTEROVIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
ESCHERICHIA SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
LISTERIA SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
LOCALISED INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
PARAINFLUENZAE VIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
PNEUMONIA ASPIRATION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
PNEUMONIA INFLUENZAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
PNEUMONIA KLEBSIELLA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
PNEUMONIA STREPTOCOCCAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
RESPIRATORY TRACT INFECTION VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
RHINOVIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
STAPHYLOCOCCAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
STREPTOCOCCAL SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
VIRAL UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
CLAVICLE FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
RIB FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
PLATELET COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPERCALCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPOPHOSPHATAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
TUMOUR LYSIS SYNDROME SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
LUMBAR SPINAL STENOSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
MUSCULAR WEAKNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
CHRONIC MYELOMONOCYTIC LEUKAEMIA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
MALIGNANT NEOPLASM PROGRESSION SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
CEREBRAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
SCIATICA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
CONFUSIONAL STATE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
ACUTE KIDNEY INJURY SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
RENAL FAILURE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
URINARY RETENTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
BENIGN PROSTATIC HYPERPLASIA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
BLOOD PHOSPHORUS INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
BLOOD THYROID STIMULATING HORMONE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
CARDIAC MURMUR SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
INTRAOCULAR PRESSURE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
LIPASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
LYMPHOCYTE COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
NEUTROPHIL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
PLATELET COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
WHITE BLOOD CELL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
DIABETES MELLITUS INADEQUATE CONTROL SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPERCALCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPERMAGNESAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPERNATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPERPHOSPHATAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPERURICAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPOALBUMINAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPOCALCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPOGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPOMAGNESAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPONATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
HYPOPHOSPHATAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
MALNUTRITION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
STEROID DIABETES SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
BONE PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
EXOSTOSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
FLANK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
MUSCULAR WEAKNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
MUSCULOSKELETAL CHEST PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
NECK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
OSTEONECROSIS OF JAW SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
SPINAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
TENDONITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
MALIGNANT MELANOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
PANCREATIC NEUROENDOCRINE TUMOUR SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
SQUAMOUS CELL CARCINOMA OF SKIN SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
COGNITIVE DISORDER SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
DYSAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
HEAD DISCOMFORT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
HEMIPARESIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
HYPERSOMNIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
NEUROPATHY PERIPHERAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
PERIPHERAL SENSORY NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
PRESYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
SEIZURE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
AGITATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
CONFUSIONAL STATE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
MOOD ALTERED SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
HAEMATURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
POLLAKIURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
PROTEINURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
ERECTILE DYSFUNCTION SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
PELVIC PAIN SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
DYSPHONIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
HICCUPS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
PRODUCTIVE COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
RHINORRHOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
SNEEZING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
UPPER-AIRWAY COUGH SYNDROME SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
WHEEZING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
ACTINIC KERATOSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
HYPERHIDROSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
HYPERKERATOSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
NIGHT SWEATS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
PAIN OF SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
PAPULE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
PURPURA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
RASH MACULO-PAPULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
SKIN ATROPHY SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
SKIN LESION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
SKIN ULCER SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
URTICARIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
EMBOLISM SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
HOT FLUSH SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
CATARACT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
EYE DISCHARGE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
EYE PAIN SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
VISUAL ACUITY REDUCED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
ABDOMINAL DISTENSION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
ABDOMINAL PAIN LOWER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
DENTAL CARIES SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
DYSPHAGIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
FLATULENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
HAEMORRHOIDS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
MOUTH ULCERATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
ODYNOPHAGIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
PARAESTHESIA ORAL SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
TRICHOGLOSSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
UMBILICAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
FACE OEDEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
FEELING COLD SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
GAIT DISTURBANCE SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
MALAISE SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
OEDEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
HYPERBILIRUBINAEMIA SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
BRONCHITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
CLOSTRIDIUM DIFFICILE COLITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
CYSTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
FUNGAL SKIN INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
HERPES ZOSTER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
LOCALISED INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
ORAL CANDIDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
OTITIS MEDIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
PARAINFLUENZAE VIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
RHINOVIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
SKIN INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
TOOTH INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
ANKLE FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
DENTAL RESTORATION FAILURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
FEMUR FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
HEAD INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
LIGAMENT SPRAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
POST PROCEDURAL HAEMATOMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
SKIN LACERATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
TONGUE INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
ACTIVATED PARTIAL THROMBOPLASTIN TIME ABNORMAL SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
BLOOD ALKALINE PHOSPHATASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
BLOOD CREATININE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
BLOOD LACTATE DEHYDROGENASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
LEUKOCYTOSIS SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
LYMPHOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
SINUS TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
EAR PAIN SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View