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 @ 2:12 AM
Ignite Modification Date:
2025-12-26 @ 12:40 AM
NCT ID:
NCT04147260
Description:
Treated Set (TS): The TS included all subjects who were randomized and treated with at least 1 dose of investigational product (IP) (BI 730357, placebo, or Ciprofloxacin). The TS was used for safety analyses.
Frequency Threshold:
5
Time Frame:
From start of treatment until end of the 7 day follow up period, 15 days in total.
Study:
NCT04147260
Study Brief:
Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo QD/BID | Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days or three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water. | 0 | None | 0 | 18 | 7 | 18 | View |
| 400 mg QD BI 730357 | Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water. | 0 | None | 0 | 27 | 9 | 27 | View |
| 300 mg BID BI 730357 | Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water. | 0 | None | 0 | 28 | 11 | 28 | View |
| 500 mg BID Ciprofloxacin (Active Comparator)) | Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg in total) over 5 days from day 3 with a single dose on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water. | 0 | None | 0 | 12 | 4 | 12 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |