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 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
NCT ID:
NCT02704702
Description:
Safety population included all population who receive at least 1 dose of study drug
Frequency Threshold:
0
Time Frame:
Participants assessed 13 days for each intervention, a total of approximately 4 weeks
Study:
NCT02704702
Study Brief:
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment C(Multiple Dose) | Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA) There will be a washout of at least 7 days between the each period. Treatment A: Fimasartan Treatment B: Rosuvastatin Treatment C: Fimasartan + Rosuvastatin | 0 | None | 0 | 34 | 8 | 34 | View |
| Treatment A(Single Dose) | Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA) There will be a washout of at least 7 days between the each period. Treatment A: Fimasartan Treatment B: Rosuvastatin Treatment C: Fimasartan + Rosuvastatin | 0 | None | 0 | 34 | 2 | 34 | View |
| Treatment A(Multiple Dose) | Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA) There will be a washout of at least 7 days between the each period. Treatment A: Fimasartan Treatment B: Rosuvastatin Treatment C: Fimasartan + Rosuvastatin | 0 | None | 0 | 33 | 6 | 33 | View |
| Treatment B(Single Dose) | Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA) There will be a washout of at least 7 days between the each period. Treatment A: Fimasartan Treatment B: Rosuvastatin Treatment C: Fimasartan + Rosuvastatin | 0 | None | 0 | 35 | 6 | 35 | View |
| Treatment B(Multiiple Dose) | Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA) There will be a washout of at least 7 days between the each period. Treatment A: Fimasartan Treatment B: Rosuvastatin Treatment C: Fimasartan + Rosuvastatin | 0 | None | 1 | 34 | 7 | 34 | View |
| Treatment C(Single Dose) | Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA) There will be a washout of at least 7 days between the each period. Treatment A: Fimasartan Treatment B: Rosuvastatin Treatment C: Fimasartan + Rosuvastatin | 0 | None | 0 | 34 | 6 | 34 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thoracic vertebral fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Right clavicle fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Right radius fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| multiple closed rib fractures | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Right sided pneumothorax | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Dizziness postural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Sensory disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Thirst | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Vessel puncture site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |