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 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
NCT ID:
NCT00404651
Description:
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
Frequency Threshold:
5.00
Time Frame:
Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Study:
NCT00404651
Study Brief:
Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in 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 |
|---|---|---|---|---|---|---|---|---|
| DTaP-IPV-HB-PRP~T Batch 2 | Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age. | None | None | 5 | 345 | 237 | 345 | View |
| DTaP-IPV-HB-PRP~T Batch 3 | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age. | None | None | 12 | 340 | 225 | 340 | View |
| Infanrix Hexa™ | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. | None | None | 6 | 167 | 95 | 167 | View |
| DTaP-IPV-HB-PRP~T Batch 1 | Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. | None | None | 5 | 337 | 220 | 337 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Heart Disease Congenital | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 9.0 | View |
| Intussusception | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Bronchopneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Ear Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Head Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Multiple Fractures | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Food Intolerance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Febrile Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Infantile Spasms | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Partial Seizures | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Asphyxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Crying | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.0 | View |
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Injection Site Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |