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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
NCT ID:
NCT00880893
Description:
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
Frequency Threshold:
5
Time Frame:
Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Study:
NCT00880893
Study Brief:
Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| CYD Dengue Vaccine Group | Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively. | 3 | None | 43 | 898 | 481 | 898 | View |
| Placebo Group | All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations. | 0 | None | 13 | 300 | 198 | 300 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Osteotomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (11.0) | View |
| Acute leukaemia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | View |
| Acute lymphocytic leukaemia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | View |
| Ovarian cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | View |
| Ovarian germ cell teratoma benign | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | View |
| Papillary thyroid cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (11.0) | View |
| Ruptured ectopic pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (11.0) | View |
| Adverse drug reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.0) | View |
| Ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11.0) | View |
| Foot fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Hand fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Intentional overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Traumatic haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Acute coronary syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Bronchial hyperreactivity | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Radial nerve palsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Syncope vasovagal | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Tension headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Gingivitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Hyperthyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (11.0) | View |
| Thyroid disorder | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (11.0) | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Conjunctivitis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Corneal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Dengue fever | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Groin abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Hand-foot-and-mouth disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Herpangina | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Lymph node tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Meningitis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Pharyngitis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Subcutaneous abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Headache; Post-Any Injection | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Injection site Pain; Post-Any Injection | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Injection site Erythema; Post-Any Injection | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Injection site Swelling; Post-Any Injection | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Fever; Post-Any Injection | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Malaise; Post-Any Injection | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Asthenia; Post-Any Injection | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Myalgia; Post-Any Injection | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |