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 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
NCT ID:
NCT01616693
Description:
Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital.
Adverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".
Frequency Threshold:
0
Time Frame:
from first day of study to 4 weeks after last dose (11 weeks)
Study:
NCT01616693
Study Brief:
Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Probiotic Alone | Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine. Probiotic: A capsule that contains at least 1 x 10\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally. Zinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily. Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks. Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks. | 0 | None | 2 | 154 | 148 | 154 | View |
| Placebo | Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine. Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally. Zinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily. Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks. Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks. | 0 | None | 4 | 155 | 146 | 155 | View |
| Zinc and Probiotic | Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines. Probiotic: A capsule that contains at least 1 x 10\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally. Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally. Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks. Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks. | 0 | None | 5 | 154 | 149 | 154 | View |
| Zinc Alone | Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine. Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally. Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally. Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks. Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks. | 0 | None | 3 | 155 | 152 | 155 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Acute febrile illness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cold/runny nose | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Any other illness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |