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 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
NCT ID:
NCT00325403
Description:
Adverse events are reported for the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228).
Frequency Threshold:
5
Time Frame:
Adverse events were recorded throughout the 12 week study which was conducted between October 2006 and April 2011.
Study:
NCT00325403
Study Brief:
FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
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 | These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population. | 6 | None | 15 | 77 | 68 | 77 | View |
| UT-15C (Oral Treprostinil) | These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population. | 9 | None | 27 | 151 | 138 | 151 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| right ventricular failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| pulmonary hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| hemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| anterograde amnesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| cardio-respiratory arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| circulatory collapse | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| collagen-vascular disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| cor pulmonale acute | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| diarrhea infectious | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| paroxysmal noturnal dypsnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| presyncope | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| pulmonary edema | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| acute renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |
| septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| skin ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| sudden death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| syncope | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| systemic lupus erythematosus | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (14.0) | View |
| urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| sudden cardiac death | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| renal impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |
| respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| pain in jaw | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| peripheral edema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (14.0) | View |
| decreased appetite | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| insomnia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| right ventricular failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| upper abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| pulmonary hypertension | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| dizziness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| pyrexia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |