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:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
NCT ID:
NCT00262002
Description:
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Frequency Threshold:
5
Time Frame:
All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Study:
NCT00262002
Study Brief:
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered 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 |
|---|---|---|---|---|---|---|---|---|
| UK24+ (MenACWY Ad+ at 2,4 m) | Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was to be given at 12 months of age. | None | None | 17 | 90 | 89 | 90 | View |
| CA24+ (MenACWY Ad+ at 2,4m) | Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age. | None | None | 4 | 98 | 97 | 98 | View |
| UK234+ (MenACWY Ad+ at 2,3,4 m) | Three doses of MenACWY Ad+ vaccine were to be given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was to be given at 12 months of age. | None | None | 20 | 90 | 90 | 90 | View |
| UKMenC (Menjugate at 2,4m) | Two doses of Menjugate® were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was to be given at 12 months of age. | None | None | 6 | 45 | 45 | 45 | View |
| CA246+ (MenACWY Ad+ at 2,4,6m) | Three doses of MenACWY Ad+ vaccine were to be given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was to be administered one dose of MMR (and Prevnar, if available) at 12 months of age. | None | None | 9 | 98 | 97 | 98 | View |
| UK24- (MenACWY Ad- at 2,4m) | Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was to be given at 12 months of age. | None | None | 10 | 90 | 90 | 90 | View |
| CA24- (MenACWY Ad- at 2,4m) | Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age. | None | None | 7 | 90 | 89 | 90 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| IDIOPATHIC THROMBOCYTOPENIC PURPURA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| SUPRAVENTRICULAR TACHYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| HYPOSPADIAS | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | None | View |
| PLAGIOCEPHALY | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | None | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| INGUINAL HERNIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| CYST | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| DEVELOPMENTAL DELAY | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| ARTHRITIS BACTERIAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| CROUP INFECTIOUS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| GASTROENTERITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| INFECTED CYST | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| INFLUENZA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| PNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| RESPIRATORY TRACT INFECTION VIRAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| SALMONELLOSIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| UPPER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| VARICELLA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| VIRAL RASH | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| BURNS FIRST DEGREE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| BURNS SECOND DEGREE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| FEMUR FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| INJURY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| URINARY RETENTION | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| ASTHMA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| BRONCHIAL HYPERREACTIVITY | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| ACROCHORDON EXCISION | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| TENDON SHEATH INCISION | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| CONGENITAL MEGACOLON | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | None | View |
| FOOD ALLERGY | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| BRONCHIOLITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| GASTROENTERITIS VIRAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| LOWER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| VIRAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| HEAD INJURY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| LIMB CRUSHING INJURY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| TRAUMATIC FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| CONVULSION | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| FEBRILE CONVULSION | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| WHEEZING | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| ERYTHEMA MULTIFORME | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| PETECHIAE | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| RASH | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| CIRCUMCISION | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| HYDROCELE OPERATION | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| INGUINAL HERNIA REPAIR | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| CONJUNCTIVITIS | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| CRYING | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| INJECTION SITE ERYTHEMA | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| INJECTION SITE INDURATION | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| INJECTION SITE PAIN | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| IRRITABILITY | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| BRONCHIOLITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| CROUP INFECTIOUS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| LOWER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| NASOPHARYNGITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| ORAL CANDIDIASIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| OTITIS MEDIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| RHINITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| UPPER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| VIRAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| EATING DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| NASAL CONGESTION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| RHINORRHOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal 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 | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| RASH | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| RASH PAPULAR | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |