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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
NCT ID:
NCT04903093
Description:
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
Frequency Threshold:
5
Time Frame:
Baseline up to follow-up (Day 36)
Study:
NCT04903093
Study Brief:
A Study Evaluating Relative Bioavailability of an Oral Suspension of Abrocitinib and Effect of an Acid Reducing Agent on the Bioavailability of Abrocitinib and Assessing the Taste of Abrocitinib Oral Formulations.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | In part A of the study, abrocitinib 200 mg commercial tablet was administered on Day 1 under fasted conditions. | 0 | None | 0 | 18 | 6 | 18 | View |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | In part A of the study, abrocitinib 200 mg oral suspension formulation 1 was administered on Day 1 under fasted conditions. | 0 | None | 0 | 18 | 8 | 18 | View |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | In part A of the study, aamotidine 40 mg tablet + Abrocitinib 200 mg commercial tablet were administered on Day 1 under fasted conditions. | 0 | None | 0 | 18 | 6 | 18 | View |
| Aborcitinib 200 mg Oral Suspension Formulation 1-6 | In part B of the study, aborcitinib 200 mg oral suspension formulation 1-6 were administered on Day 1 od each period under fasting conditions. | 0 | None | 0 | 9 | 5 | 9 | View |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Oral Suspension Formulation 1-6 | In part B of the study, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation 1-6 were administered on Day 1 of each period under fasting conditions. | 0 | None | 0 | 10 | 2 | 10 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.0 | View |
| Feeling abnormal | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.0 | View |
| Hunger | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.0 | View |
| Vessel puncture site haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.0 | View |
| Vessel puncture site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.0 | View |
| Incision site complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.0 | View |
| Incision site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.0 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.0 | View |
| Tension headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.0 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.0 | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v24.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.0 | View |