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 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
NCT ID:
NCT01049035
Description:
SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on safety population. In the AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Anorexia, respectively.
Frequency Threshold:
5
Time Frame:
Unsolicited non-serious AEs were collected from Day 0 to Day 30 post any vaccination. SRs were collected within 7 days post any vaccination. Serious adverse events were collected throughout the trial (up to the age of 13 months for Groups 1, 3, 4, 5 and 6; up to the age of 16 months for Groups 2 and 7), i.e. 30 days after last vaccination.
Study:
NCT01049035
Study Brief:
A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers
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: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months | Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months. | 0 | None | 2 | 104 | 99 | 104 | View |
| Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months | Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15. | 0 | None | 5 | 102 | 98 | 102 | View |
| Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months | Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12. | 0 | None | 7 | 100 | 98 | 100 | View |
| Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months | Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2. | 2 | None | 5 | 74 | 71 | 74 | View |
| Group 5: MenACYW Conjugate Vaccine: 12 Months | Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6. | 0 | None | 1 | 70 | 59 | 70 | View |
| Group 6: Control: 2, 4, 6, and 12 Months | Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months. | 0 | None | 4 | 52 | 51 | 52 | View |
| Group 7: Control: 2, 4, 6, 12, and 15 Months | Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15. | 0 | None | 4 | 49 | 47 | 49 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Croup Infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Gastroenteritis Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Kawasaki's Disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Lobar Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Respiratory Syncytial Virus Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Respiratory Syncytial Virus Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Staphylococcal Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Viral Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Traumatic Brain Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Head Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Skull Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Failure To Thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Febrile Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Hypoxic Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Bronchial Hyperreactivity | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Gastrooesophageal Reflux Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Teething | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Injection Site Haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Injection Site Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Croup Infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Otitis Media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Otitis Media Acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Viral Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Crying | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Nasal Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Dermatitis Diaper | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.0 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.0 | View |