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 @ 5:20 PM
Ignite Modification Date:
2025-12-25 @ 2:56 PM
NCT ID:
NCT01266850
Description:
For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Frequency Threshold:
5
Time Frame:
Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination.
Study:
NCT01266850
Study Brief:
Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group 1: RotaTeq, RotaTeq, RotaTeq | Participants received RotaTeq® orally at 2, 4 and 6 months of age. | None | None | 11 | 242 | 75 | 242 | View |
| Group 2: RotaTeq, Rotarix, Rotarix | Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age. | None | None | 7 | 248 | 95 | 248 | View |
| Group 3: RotaTeq, RotaTeq, Rotarix | Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age. | None | None | 13 | 238 | 98 | 238 | View |
| Group 4: Rotarix, Rotarix | Participants received Rotarix® orally at 2 and 4 months of age. | None | None | 11 | 329 | 85 | 329 | View |
| Group 5: Rotarix, RotaTeq, RotaTeq | Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age. | None | None | 21 | 327 | 135 | 327 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Eczema herpeticum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Meningitis aseptic | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Pneumonia bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Pneumonia respiratory syncytial viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Respiratory syncytial virus bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Staphylococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Streptococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Subcutaneous abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Urosepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Vulval cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Multiple fractures | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Skull fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Toxicity to various agents | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.0) | View |
| Failure to thrive | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.0) | View |
| Gross motor delay | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.0) | View |
| Hemiparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.0) | View |
| Apparent life threatening event | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Bronchial hyperreactivity | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Respiratory distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Status asthmaticus | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Food allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (17.0) | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Abscess neck | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Cellulitis of male external genital organ | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Croup infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Lymphadenitis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Craniosynostosis | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (17.0) | View |
| Intussusception | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |