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 @ 2:39 PM
Ignite Modification Date: 2025-12-25 @ 1:10 PM
NCT ID: NCT00384059
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00384059
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 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit. None None 1 139 111 138 View
7vPnC Infant Series Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit. None None 3 139 105 139 View
13vPnC Post-Infant Series Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit. None None 5 139 9 138 View
7vPnC Post-Infant Series Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit. None None 2 139 8 139 View
13vPnC Toddler Series Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose). None None 1 131 72 130 View
13vPnC 6-Month Follow-up Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) \& Meningococcal C Vaccine (Menitorix) at the 12-month visit (assessment at 18 months of age, 6 months after the toddler dose). None None 2 138 1 138 View
7vPnC 6-Month Follow-up Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit(assessment at 18 months of age, 6 months after the toddler dose). None None 0 139 1 139 View
7vPnC Toddler Series Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose). None None 2 122 61 122 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastrooesophaegeal reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Head injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hemiplegia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mastoiditis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Breath holding NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tongue injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Teething NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infantile spitting up NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Frequent bowel movements NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Reflux oesophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site bruising NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site induration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders None View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vessel puncture site haematoma NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders None View
Food allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Varicella NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injection site infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eczema infected NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dermatitis infected NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Impetigo NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin candida NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rubella NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eye infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Head injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Traumatic haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Radius fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Physical examination abnormal NON_SYSTEMATIC_ASSESSMENT Investigations None View
Cardiac murmur NON_SYSTEMATIC_ASSESSMENT Investigations None View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Increased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Weight gain poor NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lactose intolerance NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
High-pitched crying NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Crying NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Agitation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Restlessness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Staring NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sneezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Grunting NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eczema infantile NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Heat rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash erythematous NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Seborrhoeic dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin discolouration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Umbilical erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis allergic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders 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 (Significant) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Tenderness (Significant) 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) 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 (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 (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 (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 >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
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
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
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cyanosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dacryostenosis congenital NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Lymphangioma NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Cerumen impaction NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tympanic membrane perforation NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye discharge NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Ocular hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Astigmatism NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dacryostenosis acquired NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypermetropia NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View