Adverse Events Module

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: 2025-12-24 @ 12:35 PM
Ignite Modification Date: 2025-12-25 @ 12:11 PM
NCT ID: NCT00111761
Description: The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Frequency Threshold: 5
Time Frame: First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up)
Study: NCT00111761
Study Brief: Evaluating Panitumumab (ABX-EGF) in Patients With Metastatic Colorectal Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Panitumumab Plus IFL None None None 12 19 19 19 View
Panitumumab Plus FOLFIRI None None None 11 24 24 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Intestinal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.0 View
Colon neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 9.0 View
Colorectal cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 9.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Coagulation time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.0 View
Colon cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 9.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9.0 View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9.0 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9.0 View
Eye haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9.0 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9.0 View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9.0 View
Growth of eyelashes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9.0 View
Keratoconjunctivitis sicca SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Abdominal tenderness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Anal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Defaecation urgency SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Epigastric discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Frequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Glossodynia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Hypertrophy of tongue papillae SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Intestinal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Loose stools SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Rectal discharge SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Sensitivity of teeth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Infusion site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Rigors SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 9.0 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Biliary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Cellulitis orbital SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Genital candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
Ejection fraction abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.0 View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.0 View
Facial pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.0 View
Local swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.0 View
Ageusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Cholinergic syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.0 View
Mood swings SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.0 View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.0 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Dry throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Cold sweat SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Hair growth abnormal SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Palmar erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Rash follicular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Skin fissures SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9.0 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9.0 View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.0 View
Exfoliative rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View