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 @ 10:20 PM
Ignite Modification Date: 2025-12-25 @ 7:53 PM
NCT ID: NCT01193335
Description: SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
Frequency Threshold: 0
Time Frame: AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
Study: NCT01193335
Study Brief: Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term 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
13vPnC Group 1 (Preterm Infant) - Infant Series Preterm infant participants (GA \<37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3. None None 14 100 98 100 View
13vPnC Group 2 (Term Infant) - Infant Series Term infant participants (GA \>=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3. None None 5 100 99 100 View
13vPnC Group 1 (Preterm Infant) - After Infant Series Preterm infant participants (GA \<37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose. None None 8 100 13 100 View
13vPnC Group 2 (Term Infant) - After Infant Series Term infant participants (GA \>=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose. None None 9 100 11 100 View
13vPnC Group 1 (Preterm Infant) - Toddler Dose Preterm infant participants (GA \<37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose. None None 2 99 93 99 View
13vPnC Group 2 (Term Infant) - Toddler Dose Term infant participants (GA \>=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose. None None 1 97 92 97 View
13vPnC Group 1 (Preterm Infant) - 1 Year Follow-up Preterm infant participants (GA \<37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up. None None 13 99 2 99 View
13vPnC Group 2 (Term Infant) - 1 Year Follow-up Term infant participants (GA \>=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up. None None 8 97 0 97 View
13vPnC Group 1 (Preterm Infant) - 2 Year Follow-up Preterm infant participants (GA \<37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose. None None 6 88 1 88 View
13vPnC Group 2 (Term Infant) - 2 Year Follow-up Term infant participants (GA \>=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose. None None 8 88 1 88 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Inguinal hernia, obstructive NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intussusception NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Adenoviral upper respiratory infection 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
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia respiratory syncytial viral 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
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Human herpesvirus 6 infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis rotavirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia mycoplasmal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Encephalitis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Meningitis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Ovarian cyst torsion NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Bronchial hyperreactivity NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hydrocephalus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Loss of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Depressed level of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hip dysplasia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Cerebral palsy NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Autism spectrum disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (Unspecified) View
Arthritis reactive NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Head injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Tibia fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
CSF shunt operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (Unspecified) View
Craniotabes NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Hydrocele NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye discharge NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Viral rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cardiac murmur NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Skin papilloma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Hypersomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypotonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Subdural hygroma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Allergic respiratory disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis allergic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Seborrhoeic dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Beckwith-Wiedemann syndrome NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Allergy to arthropod sting NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Loss of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Teething NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpangina NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Developmental delay NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Tenderness- Any SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness- Any SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness- Any SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness- Mild SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness- Mild SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness- Mild SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness- Moderate SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness- Moderate SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness- Moderate SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness- Severe SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness- Severe SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness- Severe SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Swelling- Any SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Swelling- Any SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Swelling- Any SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Swelling- Mild SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Swelling- Mild SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Redness- Any SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Redness- Any SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Redness- Mild SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Redness- Mild SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Redness- Mild SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Redness- Moderate SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Redness- Moderate SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Redness- Moderate SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Redness- Severe SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Redness- Severe SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Redness- Severe SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Fever >=38 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >=38 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >=38 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >=38 degrees C, =<39 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >=38 degrees C, =<39 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >=38 degrees C, =<39 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >=39 degrees C, =<40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >=39 degrees C, =<40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >=39 degrees C, =<40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased Appetite- Any SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased Appetite- Any SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased Appetite- Any SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased Appetite- Mild SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased Appetite- Mild SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased Appetite- Mild SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased Appetite- Moderate SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased Appetite- Moderate SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased Appetite- Moderate SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased Appetite- Severe SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased Appetite- Severe SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased Appetite- Severe SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased Sleep- Any SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased Sleep- Any SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased Sleep- Any SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased Sleep- Mild SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased Sleep- Mild SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased Sleep- Mild SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased Sleep- Moderate SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased Sleep- Moderate SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased Sleep- Moderate SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased Sleep- Severe SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased Sleep- Severe SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased Sleep- Severe SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability or Decreased Sleep- Any SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability or Decreased Sleep- Any SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability or Decreased Sleep- Any SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability or Decreased Sleep- Mild SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability or Decreased Sleep- Mild SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability or Decreased Sleep- Mild SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability or Decreased Sleep-Moderate SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability or Decreased Sleep-Moderate SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability or Decreased Sleep-Moderate SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability or Decreased Sleep- Severe SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability or Decreased Sleep- Severe SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability or Decreased Sleep- Severe SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Use of Antipyretic Medication SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Use of Antipyretic Medication SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Use of Antipyretic Medication SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Food allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Milk allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Acute sinusitis 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
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Exanthema subitum 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
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral candidiasis 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
Aphthous stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Infantile colic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Umbilical hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Swelling- Mild SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Swelling- Moderate SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Swelling- Moderate SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Swelling- Moderate SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Swelling- Severe SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Swelling- Severe SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Swelling- Severe SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Redness- Any SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View