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 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 1:01 AM
NCT ID:
NCT01033734
Description:
None
Frequency Threshold:
5
Time Frame:
Up to 30 days
Study:
NCT01033734
Study Brief:
A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Oseltamivir: Overall | Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight \<= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses. | None | None | 2 | 8 | 5 | 8 | View |
| Oseltamivir: 3 to 5 Years | Participants aged 3 to 5 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight \<=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses. | None | None | 1 | 5 | 4 | 5 | View |
| Oseltamivir: 1 to 2 Years | Participants aged 1 to 2 Years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight \<=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses. | None | None | 0 | 1 | 1 | 1 | View |
| Oseltamivir: 6 to 12 Years | Participants aged 6 to 12 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight \<=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight \>40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses. | None | None | 1 | 2 | 0 | 2 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Left Ventricular Dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Catheter Site Erosion | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Device Expulsion | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Drug Withdrawal Syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Infusion Site Erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Body Temperature Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Ingrowing Nail | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Pain of Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |