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 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
NCT ID:
NCT00316693
Description:
Total number of subjects at risk corresponds to
* all subjects in the Total Vaccinated Cohort for serious events and non-systematically assessed other events;
* those subjects in the Total Vaccinated Cohort with at least one documented dose.
Frequency Threshold:
5
Time Frame:
- For serious adverse events: thoughout the study period (up to Month 24). - For other adverse events: -- during the 30-day (non-systematically assessed) or -- during the 7-day (systematically assessed) follow-up period after any vaccination.
Study:
NCT00316693
Study Brief:
Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cervarix Group | Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule. | 1 | None | 18 | 519 | 512 | 519 | View |
| Aimmugen Group | Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule. | 0 | None | 19 | 521 | 459 | 521 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | View |
| Abortion threatened | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | View |
| Acute tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Hepatitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (Unspecified) | View |
| Threatened labour | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | View |
| Abortion missed | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | View |
| Abortion spontaneous incomplete | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | View |
| Acute abdomen | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Allergic granulomatous angiitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Avulsion fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Borderline personality disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Brain contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Completed suicide | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Enterocolitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Eyeball rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Ligament injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Ligament rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Mastitis postpartum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Moyamoya disease | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Ovarian haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (Unspecified) | View |
| Panic disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Polycystic ovaries | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Pyelonephritis acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Road traffic accident | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Schizophrenia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Skull fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Redness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Gastrointestinal symptoms | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Injection site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection site warmth | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |