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 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
NCT ID:
NCT02531802
Description:
None
Frequency Threshold:
0
Time Frame:
6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Study:
NCT02531802
Study Brief:
Enterotoxigenic Escherichia Coli (ETEC) ETVAX Vaccine Trial in Bangladesh
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Adult: ETVAX (Full) | Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 0 | 15 | 0 | 15 | View |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 0 | 15 | 6 | 15 | View |
| Adult: ETVAX (Full) + 10 ug dmLT | Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 0 | 15 | 4 | 15 | View |
| Adult: Placebo | Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water | 0 | None | 0 | 15 | 1 | 15 | View |
| 24-59 Months: ETVAX (1/4) | 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 0 | 15 | 2 | 15 | View |
| 24-59 Months: ETVAX (1/2) | 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 0 | 15 | 1 | 15 | View |
| 24-59 Months: ETVAX (Full) | 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 0 | 3 | 2 | 3 | View |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 0 | 15 | 4 | 15 | View |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 0 | 15 | 1 | 15 | View |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 0 | 15 | 3 | 15 | View |
| 24-59 Months: Placebo | 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water | 0 | None | 1 | 52 | 4 | 52 | View |
| 12-23 Months: ETVAX (1/4) | 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 1 | 15 | 5 | 15 | View |
| 12-23 Months: ETVAX (1/2) | 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 0 | 15 | 2 | 15 | View |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 0 | 15 | 9 | 15 | View |
| 12-23 Months: Placebo | 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water | 0 | None | 0 | 40 | 5 | 40 | View |
| 6-11 Months: ETVAX (1/8) | 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 0 | 30 | 4 | 30 | View |
| 6-11 Months: ETVAX (1/4) | 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 0 | 30 | 8 | 30 | View |
| 6-11 Months: ETVAX (1/2) | 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 1 | 30 | 13 | 30 | View |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 0 | 30 | 9 | 30 | View |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14 | 0 | None | 0 | 30 | 8 | 30 | View |
| 6-11 Month Olds: Placebo | 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water | 0 | None | 0 | 50 | 10 | 50 | View |
Serious Events(If Any):
Serious Events
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Varicella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Dandruff | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Foreign body in eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (Unspecified) | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Measles | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Loose stools | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |