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 @ 2:12 PM
Ignite Modification Date: 2025-12-25 @ 12:51 PM
NCT ID: NCT00806195
Description: Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Frequency Threshold: 5
Time Frame: Throughout study period.
Study: NCT00806195
Study Brief: Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MenACWY-CRM197 + Routine Vaccines (All) Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs. None None 354 5760 4701 5760 View
Routine Vaccines (All) Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs. None None 114 1968 1600 1968 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Angiopathy NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Kawasaki's Disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Vasculitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Retinal Haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Anomalous Pulmonary Venous Connection NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders cMedDRA View
Congenital Absence Of Bile Ducts NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Congenital Aplastic Anaemia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Craniosynostosis NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Cryptorchism NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Hamartoma NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRAc View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Enterocolitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal Reflux Disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Inguinal Hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intussusception NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Brain Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hernia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Acute Tonsilitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Adenovirus Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bacterial Diarrhoea NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bacterial Tracheitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis Staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Croup Infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Idiopathic Thrombocytopenic Purpura NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Iron Deficiency Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Mesenteric Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Cardiac Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cyanosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Supraventricular Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ventricular Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Mitochondrial Enzyme Deficiency NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Osteognesis Imperfecta NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Patent Ductus Arteriosus NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Phimosis NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Pyloric Stenosis NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Vitello-Intestinal Duct Remnant NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Inguinal Hernia, Obstructive NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Arthritis Bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ascariasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis Streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Chest Wall Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Diarrhoea Infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dysentery NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Enterovirus Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Escherichia Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Exanthema Subitam NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Furuncle NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis Rotavirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis Salmonella NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Genital Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Groin Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Haemophilus Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hand-Foot-And-Mouth Disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpangina NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Incision Site Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infected Cyst NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Klebsiella Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lobar Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lymph Node Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Meningitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Meningitis Enteroviral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Metapneumovirus Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis Media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis Media Acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Periorbital Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Peritonsillar Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngotonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumococcal bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia Adenoviral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia Bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia Influenzal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia Primary Atypical NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia Respiratory Syncytial Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis Acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory Syncytial Virus Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory Synctial Virus Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rotavirus Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Septic Shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsilitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urachal Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary Tract Infection Enterococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Varicella NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral Diarrhoea NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Accidental Poisoning NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Craniocerebral Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Electrical Burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Foreign Body NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Head Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Humerus Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post Procedural Complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Skull Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Subdural Haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Thermal Burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Tibia Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Upper Limb Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Electrocardiogram Qt Prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Failure To Thrive NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Feeding Disorder NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Metabolic Acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Acute Disseminated Encephalomyelitis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Encephalitis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Febrile Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hydrocephalus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Myoclonic Epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Breath Holding NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Drug Abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mental Status Changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Renal Failure Acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal Mass NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Vesicoureteric Reflux NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Balanitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Scrotal mass NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Adenoidal Hypertrophy NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Apnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchial Hyperreactivity NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchomalacia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonia Aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary Oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory Distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Status Asthmaticus NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermal Cyst NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis Atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema Multiforme NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hernia Repair NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Inguinal Hernia Repair NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Lymphadenitis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Meningitis Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Subdural Hematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Staphylococcal Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Teething NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection Site Induration SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Croup Infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitits NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis Media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis Media Acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitits NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Crying SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Eating Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermatitis Diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View