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: 2025-12-24 @ 8:00 PM
Ignite Modification Date: 2025-12-25 @ 5:33 PM
NCT ID: NCT00006604
Description: P1020A followed intensive reporting requirements defined in DAIDS Serious Adverse Experience Reporting Manual. AEs graded according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-Threatening, Gr 5=Death.
Frequency Threshold: 5
Time Frame: From first study enrollment (16 November 2000) up to the last off-study visit (15 September 2014)
Study: NCT00006604
Study Brief: Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 3: ATV 520mg/m^2 Capsule 2 years and 1 day (731 days or more) to 13 years of age. ATV capsule + 2 NRTIs Note: This is the final recommended dose for this group. None None 10 21 21 21 View
Group 4: ATV 620mg/m^2 Capsule 13 years and 1 day to 21 (not including the 22nd birthday) years of age. ATV capsule + 2 NRTIs Note: This is the final recommended dose for this group. None None 15 25 25 25 View
Group 5: ATV 310mg/m^2 Powder + RTV 91 days to 2 years of age (less than or exactly 730 days. ATV powder + ritonavir + 2 NRTIs Note: This is the final recommended dose for this group. None None 12 21 21 21 View
Group 6: ATV 310mg/m^2 Powder + RTV 2 years and 1 day (731 days or more) to 13 years of age. ATV powder + ritonavir + 2 NRTIs Note: This is the final recommended dose for this group. None None 14 26 26 26 View
Group 7: ATV 205mg/m^2 Capsule + RTV 2 years and 1 day (731 days or more) to 13 years of age. ATV capsule + ritonavir + 2 NRTIs Note: This is the final recommended dose for this group. None None 15 24 24 24 View
Group 8: ATV 205mg/m^2 Capsule + RTV 13 years and 1 day to 21 (not including the 22nd birthday) years of age. ATV capsule + ritonavir + 2 NRTIs Note: This is the final recommended dose for this group. None None 8 14 14 14 View
Group 5A: ATV 310mg/m^2 Powder + RTV 91 to 180 days of age. ATV powder + ritonavir + 2 NRTIs Note: This is the final recommended dose for this group. None None 5 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bilirubin conjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood bilirubin unconjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 18.1 View
Glycosuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Facial wasting SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Lipoatrophy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Hodgkin's disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Bronchial hyperreactivity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Laryngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Nasal oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Tonsillar hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Pityriasis alba SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Lymph node pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Splenomegaly SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Middle ear effusion SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Otorrhoea SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Conjunctival hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Eye swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Ocular icterus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal tenderness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gingival ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Lip ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Oral disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Rectal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Rectal lesion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Secretion discharge SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Hepatomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Immune reconstitution inflammatory syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Serum sickness SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Acarodermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Body tinea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gingivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Helminthic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Hepatitis A SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Immune reconstitution inflammatory syndrome associated tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Meningitis haemophilus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Molluscum contagiosum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Otitis media chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Purulent discharge SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Sinusitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Skin candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Staphylococcal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Staphylococcal impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Streptococcal impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tinea capitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tinea faciei SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tinea infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tinea versicolour SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Bilirubin conjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood bilirubin SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood bilirubin unconjugated SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood bilirubin unconjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood calcium abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood calcium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood calcium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood cholesterol abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood glucose abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood glucose decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood potassium abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood sodium abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood sodium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood urea abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Breath sounds abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Cardiac murmur SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
High density lipoprotein abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Low density lipoprotein abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Pancreatic enzymes abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Abnormal weight gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Clubbing SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Lower extremity mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Skin papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Febrile convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Psychomotor hyperactivity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 18.1 View
Agoraphobia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Anger SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Anxiety disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Attention deficit/hyperactivity disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Major depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Panic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Enuresis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Amenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Fibrocystic breast disease SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Genital rash SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Perineal rash SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Vulval disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Vulvovaginal rash SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Bronchiectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Dry throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Nasal ulcer SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Paranasal sinus hypersecretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pharyngeal erythema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pharyngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pulmonary congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Rales SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Rhonchi SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Dermatitis diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Eosinophilic pustular folliculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Exfoliative rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Facial wasting SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Lipoatrophy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Lipodystrophy acquired SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Neurodermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Papule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Skin plaque SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Umbilical haematoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Urticaria chronic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View