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 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
NCT ID:
NCT06331156
Description:
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Frequency Threshold:
0
Time Frame:
Solicited AEs: Within 14 days after Dose 1 & 2: HRV PCV-free vaccine administered at Day 1 & Month 1 (Staggered group) and at Month 0.5 & Month 1.5 (Co-administration group); IPV administered at Month 0.5 & Month 1.5 (Staggered and Co-administration group), Unsolicited AEs: Within 31 days after each dose of HRV PCV-free vaccine. All-cause mortality and SAEs were collected throughout the study period (From Day 1 to Month 3.5).
Study:
NCT06331156
Study Brief:
A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese 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 |
|---|---|---|---|---|---|---|---|---|
| Staggered Group | Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5. | 0 | None | 30 | 199 | 141 | 199 | View |
| Co-administration Group | Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5. | 0 | None | 30 | 193 | 129 | 193 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Febrile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Pertussis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Pneumonia mycoplasmal | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Exanthema subitum | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Pneumonia escherichia | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Bacterial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v27.1 | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v27.1 | View |
| Functional gastrointestinal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v27.1 | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | v27.1 | View |
| Myocardial injury | SYSTEMATIC_ASSESSMENT | Cardiac disorders | v27.1 | View |
| Secondary thrombocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | v27.1 | View |
| Pelvi-ureteric obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | v27.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v27.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v27.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v27.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v27.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v27.1 | View |
| Functional gastrointestinal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v27.1 | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v27.1 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v27.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | v27.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | v27.1 | View |
| Electrolyte imbalance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | v27.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | v27.1 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | v27.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | v27.1 | View |
| Lactose intolerance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | v27.1 | View |
| Lactic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | v27.1 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | v27.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v27.1 | View |
| Nasal obstruction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v27.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v27.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v27.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v27.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v27.1 | View |
| Increased upper airway secretion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v27.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | v27.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | v27.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Candida infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Bacterial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Conjunctivitis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | v27.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v27.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v27.1 | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | v27.1 | View |
| Eczema infantile | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | v27.1 | View |
| Rash papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | v27.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | v27.1 | View |
| Eosinophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | v27.1 | View |
| Coagulopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | v27.1 | View |
| Myocardial necrosis marker increased | SYSTEMATIC_ASSESSMENT | Investigations | v27.1 | View |
| Myocardial injury | SYSTEMATIC_ASSESSMENT | Cardiac disorders | v27.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | v27.1 | View |
| Ureteric dilatation | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | v27.1 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v27.1 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v27.1 | View |
| Liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | v27.1 | View |
| Testicular swelling | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | v27.1 | View |