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 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
NCT ID:
NCT00923702
Description:
None
Frequency Threshold:
0
Time Frame:
7 years
Study:
NCT00923702
Study Brief:
Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 3-dose | The participants received three doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1, 60 and 180+. Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18. | 30 | None | 125 | 4348 | 637 | 4348 | View |
| 2-dose | The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 180+. Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18. | 22 | None | 135 | 4979 | 614 | 4979 | View |
| 2 Doses by Default | The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 60 by default (incomplete doses) Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18. | 38 | None | 292 | 3452 | 614 | 3452 | View |
| Single-dose | The participants received one dose of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) by default (incomplete doses) Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18. | 45 | None | 356 | 4950 | 296 | 4950 | View |
| Unvaccinated | A cohort of unvaccinated women | 9 | None | 0 | 4646 | 0 | 4646 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalization | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Abortion/Gynecological conditions | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Preterm delivery | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Neonatal death | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Mild: Abdominal cramps | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Diarrhea | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Dizziness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Fainting (vaso vagal reaction) within 15 to 20 minutes of vaccine receipt | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Joint stiffness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Low-grade fever (< 39°C sublingual) measurement) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Malaise | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: headaches | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: irritability | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: muscle pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Muscle spasms | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Nausea | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Neck pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Pain in extremity | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Rash | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Redness, mild tenderness or bruising around the injection site | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Sensation of heaviness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Shoulder pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Skin irritation | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild: Other specify | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Moderate: Allergic reaction [Characterized by one or more of the following: (1) skin manifestations | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Moderate: Allergic skin reactions | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Moderate: Facial edema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Moderate: High fevers sometimes associated with seizures (> 39° C) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Moderate: Larger reactions (> 2 cm) around the injection site | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Moderate: Temporary joint pain or swelling | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Moderate: Other specify | SYSTEMATIC_ASSESSMENT | General disorders | None | View |