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:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-25 @ 12:21 PM
NCT ID:
NCT06494761
Description:
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
Frequency Threshold:
5
Time Frame:
AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Study:
NCT06494761
Study Brief:
A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Repaglinide (Reference Treatment 1) | Participants received a single 0.5 mg repaglinide tablet on Day 1 of Period 1, after an overnight fast of at least 10 hours. | 0 | None | 0 | 16 | 2 | 16 | View |
| Zongertinib +Repaglinide (Test Treatment 1) | Participants received 120 mg zongertinib (two 60 mg tablets) and a single 0.5 mg repaglinide tablet on Day 1 of Period 2, after an overnight fast of at least 10 hours. | 0 | None | 0 | 16 | 4 | 16 | View |
| Zongertinib +Midazolam +Omeprazole (Test Treatment 2) | Participants received 120 mg zongertinib (two 60 mg tablets) on Day 1. On Day 2, after one day of zongertinib pretreatment, participants were administered 1 mg, midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours. | 0 | None | 0 | 14 | 4 | 14 | View |
| Zongertinib +Repaglinide (Test Treatment 3) | Participants received 0.5 mg repaglinide coadministered with zongertinib on Day 14 of Period 2, after 13 days of zongertinib pretreatment and an overnight fast. | 0 | None | 0 | 14 | 2 | 14 | View |
| Zongertinib + Midazolam + Omeprazole (Test Treatment 4) | Participants received 1 mg midazolam and 20 mg omeprazole coadministered with zongertinib on Day 15 of Period 2, after 14 days of zongertinib pretreatment and an overnight fast. | 0 | None | 0 | 14 | 4 | 14 | View |
| Midazolam + Omeprazole (Reference Treatment 2) | Participants received 1 mg midazolam (0.5 mL oral solution) coadministered with a 20 mg omeprazole tablet on Day 2 of Period 1, following an overnight fast of at least 10 hours. | 0 | None | 0 | 16 | 2 | 16 | View |
| Zongertinib | Participants received 120 mg zongertinib daily (as two 60 mg tablets) from Day 1 to Day 15 of Period 2. | 0 | None | 0 | 14 | 9 | 14 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrioventricular block second degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 27.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | View |
| Cold sweat | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.0 | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.0 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.0 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 27.0 | View |
| Phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 27.0 | View |
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 27.0 | View |