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 @ 4:11 PM
Ignite Modification Date: 2025-12-25 @ 2:11 PM
NCT ID: NCT00368966
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00368966
Study Brief: Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in 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 Infant Series Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age. None None 16 314 151 314 View
7vPnC Infant Series Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age. None None 16 300 156 300 View
13vPnC Post-Infant Series Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series), assessment was done approximately one month after dose 3 at 7 months of age. None None 16 314 7 314 View
7vPnC Post-Infant Series Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months, assessment was done approximately one month after dose 3 at 7 months of age. None None 16 300 10 300 View
13vPnC Toddler Series Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age. None None 3 291 124 291 View
7vPnC Toddler Series Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age. None None 1 284 110 284 View
13vPnC 6-Month Follow-up Assessment was done approximately 6 months after 13vPnC toddler dose at 21 months of age. None None 3 312 3 312 View
7vPnC 6-Month Follow-up Assessment was done approximately 6 months after 7vPnC toddler dose at 21 months of age. None None 6 299 2 299 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Apnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Arthritis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Congenital nystagmus NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Cytomegalovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fontanelle bulging NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis rotavirus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis salmonella NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypotonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Infected cyst NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lobar pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lymphadenitis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Meningitis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Partial seizures NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pharyngotonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Respiratory syncytial virus bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rotavirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Scaphocephaly NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Skull fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Epstein-Barr virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sudden infant death syndrome NON_SYSTEMATIC_ASSESSMENT General disorders None View
Synovitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tuberculosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Induration (Moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pyelocaliectasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hip dysplasia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Atrial septal defect NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Double ureter NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Hydrocele NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Hypospadias NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Strabismus congenital NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Otorrhoea NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dacryostenosis acquired NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjuctivitis allergic NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Coeliac disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal inflammation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cyst NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypothermia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Milk allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Food allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Coxsackie viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Varicella NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tuberculosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dacryocystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis rotavirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acarodermatitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fungal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpangina NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Impetigo NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin candida NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tracheitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Head injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Traumatic brain injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dermatitis atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Seborrhoeic dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash generalised NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bronchitis chronic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Penis disorder NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Testicular retraction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Genital rash NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Lactose intolerance NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Torticollis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Exposure to communicable disease NON_SYSTEMATIC_ASSESSMENT Social circumstances None 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) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness (Significant) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness (Significant) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness (Significant) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Mild) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Fever ≥38°C but ≤39°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever ≥38°C but ≤39°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever ≥38°C but ≤39°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >39°C but ≤40°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >39°C but ≤40°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >39°C but ≤40°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >40°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >40°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >40°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Bronchial hyperreactivity NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View