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 A: Low Dose Prucalopride | Participants weighing \<50 kg received 0.04 mg/kg of prucalopride oral solution (drew the required volume from one bottle of 0.4 mg/mL and one bottle of placebo oral solution), QD or participants weighing ≥50 kg received one 2 mg of prucalopride oral tablet and one placebo oral tablet, QD, during 12 weeks in Part A. Prucalopride (oral solution or tablet) were dosed depending on the participant's BW at the randomization visit. | 0 | None | 0 | 60 | 17 | 60 | View |
| Part A: Placebo | Participants weighing \<50 kg drew equal volumes from two bottles of placebo oral solution to account for the daily dose assigned or participants weighing ≥50 kg received two placebo oral tablets, QD, during 12 weeks in Part A. Prucalopride matching placebo (oral solution or tablet) were dosed depending on the participant's BW at the randomization visit. | 0 | None | 1 | 56 | 5 | 56 | View |
| Part A: High Dose Prucalopride | Participants weighing \<50 kg received 0.08 mg/kg of prucalopride oral solution (drew the required volume from two bottles of 0.4 mg/mL to account for the daily dose assigned), QD or participants weighing ≥50 kg received two 2 mg of prucalopride oral tablets, QD, during 12 weeks of treatment period in Part A. Prucalopride (oral solution or tablet) were dosed depending on the participant's BW at the randomization visit. | 0 | None | 0 | 59 | 10 | 59 | View |
| Part B: Low Dose Prucalopride | Participants weighing \<50 kg received 0.04 mg/kg of prucalopride oral solution (drew the required volume from one bottle of 0.4 mg/mL and one bottle of placebo oral solution to account for the daily dose assigned), QD or participants weighing ≥50 kg received one 2 mg of prucalopride oral tablet and one placebo oral tablet, QD, for 36 weeks during the 40-week Part B Period. Prucalopride (oral solution or tablet) were dosed depending on the participant's BW at the randomization visit. | 0 | None | 1 | 72 | 9 | 72 | View |
| Part B: High Dose Prucalopride | Participants weighing \<50 kg received 0.08 mg/kg of prucalopride oral solution (drew the required volume from two bottles of 0.4 mg/mL to account for the daily dose assigned), QD or participants weighing ≥50 kg received two 2 mg of prucalopride oral tablets, QD, for 36 weeks during the 40-week Part B Period. Prucalopride (oral solution or tablet) were dosed depending on the participant's BW at the randomization visit. | 0 | None | 1 | 62 | 8 | 62 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26 | View |
| Intentional self-injury | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26 | View |