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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part 1, Cohort 6: Levo Praziquantel 45 mg/kg | Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 45 mg/kg as a single dose on treatment Day 1. | 0 | None | 0 | 60 | 33 | 60 | View |
| Part 2, Cohort 8: Levo Praziquantel 50 mg/kg | Participants aged 13-24 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1. | 0 | None | 0 | 20 | 10 | 20 | View |
| Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg | Participants received Biltricide (600 mg tablet) administered orally at a dose of 20 milligram per kilogram (mg/kg), three times a day on treatment Day 1. | 0 | None | 1 | 60 | 25 | 60 | View |
| Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg | Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1. | 0 | None | 0 | 60 | 30 | 60 | View |
| Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg | Participants received Racemate Praziquantel oral dispersible tablet (ODT) (150 mg) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1. | 0 | None | 1 | 60 | 29 | 60 | View |
| Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg | Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1. | 0 | None | 0 | 60 | 31 | 60 | View |
| Part 1, Cohort 5: Levo Praziquantel 30 mg/kg | Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 30 mg/kg as a single dose on treatment Day 1. | 0 | None | 0 | 60 | 28 | 60 | View |
| Part 1, Cohort 7: Levo Praziquantel 60 mg/kg | Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1. | 0 | None | 0 | 60 | 37 | 60 | View |
| Part 2, Cohort 9: Levo Praziquantel 50 mg/kg | Participants aged 3 to 12 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1. | 0 | None | 0 | 4 | 4 | 4 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Malaria | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| C-reactive protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |